K952584 is an FDA 510(k) clearance for the GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK. This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Gamp & Assoc. (Bridgeton, US). The FDA issued a Cleared decision on September 1, 1995, 88 days after receiving the submission on June 5, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K952584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1995 |
| Decision Date | September 01, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | MPA — Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |