K973552 is an FDA 510(k) clearance for the OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP. This device is classified as a Wrap, Implant, Orbital (Class II - Special Controls, product code MTZ).
Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 16, 1997, 88 days after receiving the submission on September 19, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3320.
| 510(k) Number | K973552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MTZ — Wrap, Implant, Orbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3320 |