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Title 21 - Food and Drugs
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CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898)
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PART 878—GENERAL AND PLASTIC SURGERY DEVICES
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SUBPART E—Surgical Devices (§878.4010 to §878.5040)
CFR
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SUBPART E—Surgical Devices (§878.4010 to §878.5040)
878.4010—Tissue adhesive.
878.4011—Tissue adhesive with adjunct wound closure device for topical approximation of skin.
878.4014—Nonresorbable gauze/sponge for external use.
878.4015—Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
878.4018—Hydrophilic wound dressing.
878.4020—Occlusive wound dressing.
878.4022—Hydrogel wound dressing and burn dressing.
878.4025—Silicone sheeting.
878.4040—Surgical apparel.
878.4100—Organ bag.
878.4160—Surgical camera and accessories.
878.4200—Introduction/drainage catheter and accessories.
878.4300—Implantable clip.
878.4320—Removable skin clip.
878.4340—Contact cooling system for aesthetic use.
878.4350—Cryosurgical unit and accessories.
878.4370—Surgical drape and drape accessories.
878.4380—Drape adhesive.
878.4400—Electrosurgical cutting and coagulation device and accessories.
878.4410—Low energy ultrasound wound cleaner.
878.4440—Eye pad.
878.4450—Nonabsorbable gauze for internal use.
878.4460—Surgeon's glove.
878.4470—Surgeon's gloving cream.
878.4480—Absorbable powder for lubricating a surgeon's glove.
878.4490—Absorbable hemostatic agent and dressing.
878.4493—Absorbable poly(glycolide/ l -lactide) surgical suture.
878.4494—Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
878.4495—Stainless steel suture.
878.4520—Polytetrafluoroethylene injectable.
878.4580—Surgical lamp.
878.4630—Ultraviolet lamp for dermatologic disorders.
878.4635—Ultraviolet lamp for tanning.
878.4660—Skin marker.
878.4680—Nonpowered, single patient, portable suction apparatus.
878.4683—Non-Powered suction apparatus device intended for negative pressure wound therapy.
878.4700—Surgical microscope and accessories.
878.4730—Surgical skin degreaser or adhesive tape solvent.
878.4750—Implantable staple.
878.4760—Removable skin staple.
878.4780—Powered suction pump.
878.4800—Manual surgical instrument for general use.
878.4810—Laser surgical instrument for use in general and plastic surgery and in dermatology.
878.4820—Surgical instrument motors and accessories/attachments.
878.4830—Absorbable surgical gut suture.
878.4840—Absorbable polydioxanone surgical suture.
878.4930—Suture retention device.
878.4950—Manual operating table and accessories and manual operating chair and accessories.
878.4960—Operating tables and accessories and operating chairs and accessories.
878.5000—Nonabsorbable poly(ethylene terephthalate) surgical suture.
878.5010—Nonabsorbable polypropylene surgical suture.
878.5020—Nonabsorbable polyamide surgical suture.
878.5030—Natural nonabsorbable silk surgical suture.
878.5035—Nonabsorbable expanded polytetrafluoroethylene surgical suture.
878.5040—Suction lipoplasty system.
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