K961524 is an FDA 510(k) clearance for the STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS. This device is classified as a Cystotome (Class I - General Controls, product code HNY).
Submitted by Sterilab, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 16, 1996, 24 days after receiving the submission on April 22, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K961524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1996 |
| Decision Date | May 16, 1996 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HNY — Cystotome |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |