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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
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 | 880.1 | Scope. |
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| 880.3 | Effective dates of requirement for premarket approval. |
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| 880.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 880.2200 | Liquid crystal forehead temperature strip. |
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| 880.2400 | Bed-patient monitor. |
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| 880.2420 | Electronic monitor for gravity flow infusion systems. |
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| 880.2460 | Electrically powered spinal fluid pressure monitor. |
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| 880.2500 | Spinal fluid manometer. |
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| 880.2700 | Stand-on patient scale. |
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| 880.2720 | Patient scale. |
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| 880.2740 | Surgical sponge scale. |
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| 880.2800 | Sterilization process indicator. |
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| 880.2900 | Clinical color change thermometer. |
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| 880.2910 | Clinical electronic thermometer. |
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| 880.2920 | Clinical mercury thermometer. |
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| 880.2930 | Apgar timer. |
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| 880.5025 | I.V. container. |
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| 880.5045 | Medical recirculating air cleaner. |
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| 880.5075 | Elastic bandage. |
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| 880.5090 | Liquid bandage. |
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| 880.5100 | AC-powered adjustable hospital bed. |
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| 880.5110 | Hydraulic adjustable hospital bed. |
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| 880.5120 | Manual adjustable hospital bed. |
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| 880.5130 | Infant radiant warmer. |
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| 880.5140 | Pediatric hospital bed. |
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| 880.5150 | Nonpowered flotation therapy mattress. |
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| 880.5160 | Therapeutic medical binder. |
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| 880.5180 | Burn sheet. |
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| 880.5200 | Intravascular catheter. |
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| 880.5210 | Intravascular catheter securement device. |
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| 880.5240 | Medical adhesive tape and adhesive bandage. |
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| 880.5270 | Neonatal eye pad. |
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| 880.5300 | Medical absorbent fiber. |
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| 880.5400 | Neonatal incubator. |
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| 880.5410 | Neonatal transport incubator. |
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| 880.5420 | Pressure infusor for an I.V. bag. |
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| 880.5430 | Nonelectrically powered fluid injector. |
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| 880.5440 | Intravascular administration set. |
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| 880.5450 | Patient care reverse isolation chamber. |
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| 880.5475 | Jet lavage. |
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| 880.5500 | AC-powered patient lift. |
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| 880.5510 | Non-AC-powered patient lift. |
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| 880.5550 | Alternating pressure air flotation mattress. |
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| 880.5560 | Temperature regulated water mattress. |
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| 880.5570 | Hypodermic single lumen needle. |
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| 880.5580 | Acupuncture needle. |
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| 880.5630 | Nipple shield. |
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| 880.5640 | Lamb feeding nipple. |
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| 880.5680 | Pediatric position holder. |
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| 880.5700 | Neonatal phototherapy unit. |
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| 880.5725 | Infusion pump. |
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| 880.5740 | Suction snakebite kit. |
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| 880.5760 | Chemical cold pack snakebite kit. |
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| 880.5780 | Medical support stocking. |
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| 880.5820 | Therapeutic scrotal support. |
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| 880.5860 | Piston syringe. |
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| 880.5950 | Umbilical occlusion device. |
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| 880.5960 | Lice removal kit. |
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| 880.6025 | Absorbent tipped applicator. |
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| 880.6050 | Ice bag. |
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| 880.6060 | Medical disposable bedding. |
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| 880.6070 | Bed board. |
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| 880.6080 | Cardiopulmonary resuscitation board. |
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| 880.6085 | Hot/cold water bottle. |
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| 880.6100 | Ethylene oxide gas aerator cabinet. |
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| 880.6140 | Medical chair and table. |
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| 880.6150 | Ultrasonic cleaner for medical instruments. |
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| 880.6185 | Cast cover. |
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| 880.6190 | Mattress cover for medical purposes. |
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| 880.6200 | Ring cutter. |
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| 880.6230 | Tongue depressor. |
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| 880.6250 | Patient examination glove. |
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| 880.6265 | Examination gown. |
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| 880.6280 | Medical insole. |
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| 880.6320 | AC-powered medical examination light. |
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| 880.6350 | Battery-powered medical examination light. |
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| 880.6375 | Patient lubricant. |
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| 880.6430 | Liquid medication dispenser. |
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| 880.6450 | Skin pressure protectors. |
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| 880.6500 | Medical ultraviolet air purifier. |
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| 880.6710 | Medical ultraviolet water purifier. |
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| 880.6730 | Body waste receptacle. |
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| 880.6740 | Vacuum-powered body fluid suction apparatus. |
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| 880.6760 | Protective restraint. |
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| 880.6775 | Powered patient transfer device. |
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| 880.6785 | Manual patient transfer device. |
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| 880.6800 | Washers for body waste receptacles. |
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| 880.6820 | Medical disposable scissors. |
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| 880.6850 | Sterilization wrap. |
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| 880.6860 | Ethylene oxide gas sterilizer. |
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| 880.6870 | Dry-heat sterilizer. |
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| 880.6880 | Steam sterilizer. |
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| 880.6900 | Hand-carried stretcher. |
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| 880.6910 | Wheeled stretcher. |
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| 880.6920 | Syringe needle introducer. |
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| 880.6960 | Irrigating syringe. |
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| 880.6970 | Liquid crystal vein locator. |
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| 880.6980 | Vein stabilizer. |
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| 880.6990 | Infusion stand. |
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