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Section 878.1
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Effective dates of requirement for premarket approval |
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Section 878.3
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) |
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Section 878.9
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Speculum and accessories |
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Section 878.1800
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External facial fracture fixation appliance |
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Section 878.3250
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Surgical mesh |
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Section 878.3300
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Polytetrafluoroethylene with carbon fibers composite implant material |
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Section 878.3500
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Silicone inflatable breast prosthesis |
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Section 878.3530
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Silicone gel-filled breast prosthesis |
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Section 878.3540
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Chin prosthesis |
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Section 878.3550
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Ear prosthesis |
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Section 878.3590
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Esophageal prosthesis |
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Section 878.3610
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Nose prosthesis |
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Section 878.3680
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Tracheal prosthesis |
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Section 878.3720
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External prosthesis adhesive |
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Section 878.3750
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External aesthetic restoration prosthesis |
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Section 878.3800
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Inflatable extremity splint |
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Section 878.3900
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Noninflatable extremity splint |
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Section 878.3910
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Plastic surgery kit and accessories |
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Section 878.3925
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Tissue adhesive |
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Section 878.4010
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Tissue adhesive with adjunct wound closure device for topical approximation of skin |
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Section 878.4011
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Nonresorbable gauze/sponge for external use |
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Section 878.4014
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Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive |
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Section 878.4015
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Hydrophilic wound dressing |
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Section 878.4018
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Occlusive wound dressing |
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Section 878.4020
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Hydrogel wound dressing and burn dressing |
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Section 878.4022
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Silicone sheeting |
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Section 878.4025
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Surgical apparel |
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Section 878.4040
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Organ bag |
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Section 878.4100
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Surgical camera and accessories |
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Section 878.4160
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Introduction/drainage catheter and accessories |
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Section 878.4200
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Implantable clip |
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Section 878.4300
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Removable skin clip |
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Section 878.4320
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Contact cooling system for aesthetic use |
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Section 878.4340
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Cryosurgical unit and accessories |
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Section 878.4350
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Surgical drape and drape accessories |
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Section 878.4370
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Drape adhesive |
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Section 878.4380
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Electrosurgical cutting and coagulation device and accessories |
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Section 878.4400
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Low energy ultrasound wound cleaner |
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Section 878.4410
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Eye pad |
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Section 878.4440
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Nonabsorbable gauze for internal use |
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Section 878.4450
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Nonabsorbable expandable hemostatic sponge for temporary internal use |
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Section 878.4452
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Surgeon's glove |
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Section 878.4460
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Surgeon's gloving cream |
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Section 878.4470
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Absorbable powder for lubricating a surgeon's glove |
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Section 878.4480
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Absorbable hemostatic agent and dressing |
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Section 878.4490
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Absorbable poly(glycolide/l-lactide) surgical suture |
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Section 878.4493
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Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology |
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Section 878.4494
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Stainless steel suture |
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Section 878.4495
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Polytetrafluoroethylene injectable |
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Section 878.4520
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Surgical lamp |
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Section 878.4580
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Focused ultrasound stimulator system for aesthetic use |
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Section 878.4590
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Ultraviolet lamp for dermatologic disorders |
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Section 878.4630
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Sunlamp products and ultraviolet lamps intended for use in sunlamp products |
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Section 878.4635
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Skin marker |
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Section 878.4660
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Nonpowered, single patient, portable suction apparatus |
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Section 878.4680
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Non-Powered suction apparatus device intended for negative pressure wound therapy |
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Section 878.4683
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Surgical microscope and accessories |
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Section 878.4700
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Surgical skin degreaser or adhesive tape solvent |
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Section 878.4730
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Implantable staple |
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Section 878.4750
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Absorbable lung biopsy plug |
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Section 878.4755
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Removable skin staple |
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Section 878.4760
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Powered suction pump |
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Section 878.4780
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Powered surgical instrument for improvement in the appearance of cellulite |
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Section 878.4790
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Manual surgical instrument for general use |
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Section 878.4800
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Laser surgical instrument for use in general and plastic surgery and in dermatology |
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Section 878.4810
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Surgical instrument motors and accessories/attachments |
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Section 878.4820
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Absorbable surgical gut suture |
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Section 878.4830
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Absorbable polydioxanone surgical suture |
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Section 878.4840
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Suture retention device |
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Section 878.4930
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Manual operating table and accessories and manual operating chair and accessories |
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Section 878.4950
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Operating tables and accessories and operating chairs and accessories |
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Section 878.4960
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Nonabsorbable poly(ethylene terephthalate) surgical suture |
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Section 878.5000
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Nonabsorbable polypropylene surgical suture |
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Section 878.5010
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Nonabsorbable polyamide surgical suture |
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Section 878.5020
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Natural nonabsorbable silk surgical suture |
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Section 878.5030
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Nonabsorbable expanded polytetrafluoroethylene surgical suture |
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Section 878.5035
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Suction lipoplasty system |
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Section 878.5040
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Air-handling apparatus for a surgical operating room |
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Section 878.5070
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Needle-type epilator |
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Section 878.5350
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Tweezer-type epilator |
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Section 878.5360
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Low level laser system for aesthetic use |
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Section 878.5400
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Topical oxygen chamber for extremities |
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Section 878.5650
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Nonpneumatic tourniquet |
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Section 878.5900
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Pneumatic tourniquet |
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Section 878.5910
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Scope |