GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP
Device Facts
| Record ID | K897119 |
|---|---|
| Device Name | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP |
| Applicant | Grieshaber & Co. |
| Product Code | HQW · Ophthalmic |
| Decision Date | Apr 12, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3100 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
