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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
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 | 876.1 | Scope. |
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| 876.3 | Effective dates of requirement for premarket approval. |
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| 876.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 876.1075 | Gastroenterology-urology biopsy instrument. |
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| 876.1400 | Stomach pH electrode. |
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| 876.1500 | Endoscope and accessories. |
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| 876.1620 | Urodynamics measurement system. |
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| 876.1725 | Gastrointestinal motility monitoring system. |
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| 876.1735 | Electrogastrography system. |
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| 876.1800 | Urine flow or volume measuring system. |
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| 876.2040 | Enuresis alarm. |
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| 876.3350 | Penile inflatable implant. |
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| 876.3630 | Penile rigidity implant. |
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| 876.3750 | Testicular prosthesis. |
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| 876.4020 | Fiberoptic light ureteral catheter. |
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| 876.4270 | Colostomy rod. |
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| 876.4300 | Endoscopic electrosurgical unit and accessories. |
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| 876.4370 | Gastroenterology-urology evacuator. |
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| 876.4400 | Hemorrhoidal ligator. |
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| 876.4480 | Electrohydraulic lithotriptor. |
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| 876.4480 | Electrohydraulic lithotriptor. |
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| 876.4500 | Mechanical lithotriptor. |
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| 876.4530 | Gastroenterology-urology fiberoptic retractor. |
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| 876.4560 | Ribdam. |
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| 876.4590 | Interlocking urethral sound. |
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| 876.4620 | Ureteral stent. |
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| 876.4650 | Water jet renal stone dislodger system. |
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| 876.4680 | Ureteral stone dislodger. |
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| 876.4730 | Manual gastroenterology-urology surgical instrument and accessories. |
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| 876.4770 | Urethrotome. |
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| 876.4890 | Urological table and accessories. |
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| 876.5010 | Biliary catheter and accessories. |
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| 876.5030 | Continent ileostomy catheter. |
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| 876.5090 | Suprapubic urological catheter and accessories. |
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| 876.5130 | Urological catheter and accessories. |
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| 876.5160 | Urological clamp for males. |
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| 876.5210 | Enema kit. |
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| 876.5220 | Colonic irrigation system. |
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| 876.5250 | Urine collector and accessories. |
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| 876.5270 | Implanted electrical urinary continence device. |
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| 876.5280 | Implanted mechanical/hydraulic urinary continence device. |
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| 876.5320 | Nonimplanted electrical continence device. |
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| 876.5365 | Esophageal dilator. |
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| 876.5450 | Rectal dilator. |
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| 876.5470 | Ureteral dilator. |
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| 876.5520 | Urethral dilator. |
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| 876.5540 | Blood access device and accessories. |
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| 876.5600 | Sorbent regenerated dialysate delivery system for hemodialysis. |
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| 876.5630 | Peritoneal dialysis system and accessories. |
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| 876.5665 | Water purification system for hemodialysis. |
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| 876.5820 | Hemodialysis system and accessories. |
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| 876.5830 | Hemodialyzer with disposable insert (Kiil type). |
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| 876.5860 | High permeability hemodialysis system. |
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| 876.5860 | High permeability hemodialysis system. |
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| 876.5870 | Sorbent hemoperfusion system. |
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| 876.5880 | Isolated kidney perfusion and transport system and accessories. |
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| 876.5895 | Ostomy irrigator. |
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| 876.5900 | Ostomy pouch and accessories. |
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| 876.5920 | Protective garment for incontinence. |
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| 876.5955 | Peritoneo-venous shunt. |
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| 876.5955 | Peritoneo-venous shunt. |
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| 876.5970 | Hernia support. |
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| 876.5980 | Gastrointestinal tube and accessories. |
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