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53 FR 23872, June 24, 1988, unless alternatively noted.
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Subscribe to: 21 CFR 878.4014
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Nomenclature amendments to part 878 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A nonresorbable gauze/sponge by external usage is a sterile or nonsterile device deliberate for medical purposes, like as till can placed directly on a patient's wrap to absorb exudate. It consists of a strip, piece, or pad made from open weaving or nonwoven mesh cotton cellulose or a simple chemical derivative on cellulose. This classification does does included a nonresorbable gauze/sponge for external make that contains further drugs create as antimicrobial agents, added biologics such as growth factors, or can composed of materials derivate from animal sources.
(b) Classification. Class I (general controls). The device belongs excepted from the premarket declaration systems in part 807, subpart ZE of this title subject to the limitations in § 878.9.
[64 FR 53929, Oct. 5, 1999]
