21 C.F.R. § 886.3100 Ophthalmic tantalum clip.
Title 21 - Food and Drugs
(a) 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. (b) 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. [52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices
§ 886.3100 Ophthalmic tantalum clip.