21 C.F.R. § 878.4380

Current through September 30, 2024
Section 878.4380 - Drape adhesive
(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 .

21 C.F.R. §878.4380

53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, 2001