§886.3100. Ophthalmic tantalum clip.
21 C.F.R. § 886.3100
Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently or temporarily to bring together the edges of a wound to aid healing or prevent bleeding from small blood vessels in the eye.
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Notes, amendments, and revision history
Amendments
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
Amendments
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]