§ 878.4380. Drape adhesive.
72 words·~1 min read·
/us/cfr/t21/s§ 878.4380·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001]