21 C.F.R. § 880.5950

Current through October 31, 2024
Section 880.5950 - Umbilical occlusion device
(a)Identification. An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
(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 § 880.9 .

21 C.F.R. §880.5950

45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805 , July 25, 2001