K831916 is an FDA 510(k) clearance for the DISPOSABLE CYSTOTOME. This device is classified as a Cystotome (Class I - General Controls, product code HNY).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on July 12, 1983, 28 days after receiving the submission on June 14, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K831916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1983 |
| Decision Date | July 12, 1983 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNY — Cystotome |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |