O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
Device Facts
| Record ID | K901002 |
|---|---|
| Device Name | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES |
| Applicant | Oculo Plastik, Inc. |
| Product Code | HQX · Ophthalmic |
| Decision Date | May 22, 1990 |
| 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.
