RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
Device Facts
| Record ID | K963219 |
|---|---|
| Device Name | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES |
| Applicant | Fci Ophthalmics, Inc. |
| Product Code | HQX · Ophthalmic |
| Decision Date | Oct 28, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
