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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 882--NEUROLOGICAL DEVICES
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 | 882.1 | Scope. |
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| 882.3 | Effective dates of requirement for premarket approval. |
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| 882.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 882.1020 | Rigidity analyzer. |
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| 882.1030 | Ataxiagraph. |
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| 882.1200 | Two-point discriminator. |
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| 882.1240 | Echoencephalograph. |
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| 882.1275 | Electroconductive media. |
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| 882.1310 | Cortical electrode. |
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| 882.1320 | Cutaneous electrode. |
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| 882.1330 | Depth electrode. |
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| 882.1340 | Nasopharyngeal electrode. |
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| 882.1350 | Needle electrode. |
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| 882.1400 | Electroencephalograph. |
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| 882.1410 | Electroencephalograph electrode/lead tester. |
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| 882.1420 | Electroencephalogram (EEG) signal spectrum analyzer. |
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| 882.1430 | Electroencephalograph test signal generator. |
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| 882.1460 | Nystagmograph. |
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| 882.1480 | Neurological endoscope. |
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| 882.1500 | Esthesiometer. |
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| 882.1525 | Tuning fork. |
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| 882.1540 | Galvanic skin response measurement device. |
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| 882.1550 | Nerve conduction velocity measurement device. |
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| 882.1560 | Skin potential measurement device. |
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| 882.1570 | Powered direct-contact temperature measurement device. |
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| 882.1610 | Alpha monitor. |
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| 882.1620 | Intracranial pressure monitoring device. |
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| 882.1700 | Percussor. |
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| 882.1750 | Pinwheel. |
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| 882.1790 | Ocular plethysmograph. |
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| 882.1825 | Rheoencephalograph. |
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| 882.1835 | Physiological signal amplifier. |
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| 882.1845 | Physiological signal conditioner. |
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| 882.1855 | Electroencephalogram (EEG) telemetry system. |
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| 882.1870 | Evoked response electrical stimulator. |
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| 882.1880 | Evoked response mechanical stimulator. |
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| 882.1890 | Evoked response photic stimulator. |
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| 882.1900 | Evoked response auditory stimulator. |
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| 882.1925 | Ultrasonic scanner calibration test block. |
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| 882.1950 | Tremor transducer. |
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| 882.4030 | Skull plate anvil. |
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| 882.4060 | Ventricular cannula. |
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| 882.4100 | Ventricular catheter. |
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| 882.4125 | Neurosurgical chair. |
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| 882.4150 | Scalp clip. |
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| 882.4175 | Aneurysm clip applier. |
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| 882.4190 | Clip forming/cutting instrument. |
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| 882.4200 | Clip removal instrument. |
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| 882.4215 | Clip rack. |
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| 882.4250 | Cryogenic surgical device. |
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| 882.4275 | Dowel cutting instrument. |
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| 882.4300 | Manual cranial drills, burrs, trephines, and their accessories |
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| 882.4305 | Powered compound cranial drills, burrs, trephines, and their accessories. |
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| 882.4310 | Powered simple cranial drills, burrs, trephines, and their accessories. |
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| 882.4325 | Cranial drill handpiece (brace). |
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| 882.4360 | Electric cranial drill motor. |
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| 882.4370 | Pneumatic cranial drill motor. |
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| 882.4400 | Radiofrequency lesion generator. |
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| 882.4440 | Neurosurgical headrests. |
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| 882.4460 | Neurosurgical head holder (skull clamp). |
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| 882.4500 | Cranioplasty material forming instrument. |
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| 882.4525 | Microsurgical instrument. |
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| 882.4535 | Nonpowered neurosurgical instrument. |
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| 882.4545 | Shunt system implantation instrument. |
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| 882.4560 | Stereotaxic instrument. |
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| 882.4600 | Leukotome. |
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| 882.4650 | Neurosurgical suture needle. |
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| 882.4700 | Neurosurgical paddie. |
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| 882.4725 | Radiofrequency lesion probe. |
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| 882.4750 | Skull punch. |
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| 882.4800 | Self-retaining retractor for neurosurgery. |
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| 882.4840 | Manual rongeur. |
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| 882.4845 | Powered rongeur. |
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| 882.4900 | Skullplate screwdriver. |
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| 882.5030 | Methyl methacrylate for aneurysmorrhaphy. |
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| 882.5050 | Biofeedback device. |
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| 882.5070 | Bite block. |
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| 882.5150 | Intravascular occluding catheter. |
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| 882.5175 | Carotid artery clamp. |
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| 882.5200 | Aneurysm clip. |
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| 882.5225 | Implanted malleable clip. |
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| 882.5235 | Aversive conditioning device. |
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| 882.5250 | Burr hole cover. |
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| 882.5275 | Nerve cuff. |
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| 882.5300 | Methyl methacrylate for cranioplasty. |
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| 882.5320 | Preformed alterable cranioplasty plate. |
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| 882.5330 | Preformed nonalterable cranioplasty plate. |
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| 882.5360 | Cranioplasty plate fastener. |
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| 882.5500 | Lesion temperature monitor. |
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| 882.5550 | Central nervous system fluid shunt and components. |
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| 882.5800 | Cranial electrotheraphy stimulator. |
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| 882.5810 | External functional neuromuscular stimulator. |
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| 882.5820 | Implanted cerebellar stimulator. |
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| 882.5830 | Implanted diaphragmatic/phrenic nerve stimulator. |
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| 882.5840 | Implanted intracerebral/subcortical stimulator for pain relief. |
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| 882.5850 | Implanted spinal cord stimulator for bladder evacuation. |
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| 882.5860 | Implanted neuromuscular stimulator. |
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| 882.5870 | Implanted peripheral nerve stimulator for pain relief. |
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| 882.5880 | Implanted spinal cord stimulator for pain relief. |
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| 882.5890 | Transcutaneous electrical nerve stimulator for pain relief. |
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| 882.5900 | Preformed craniosynostosis strip. |
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| 882.5910 | Dura substitute. |
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| 882.5940 | Electroconvulsive therapy device. |
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| 882.5950 | Neurovascular embolization device. |
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| 882.5960 | Skull tongs for traction. |
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| 882.5970 | Cranial orthosis. |
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| 882.5975 | Human dura mater. |
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