K870265 is an FDA 510(k) clearance for the KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR. This device is classified as a Lens, Guide, Intraocular (Class I - General Controls, product code KYB).
Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on February 20, 1987, 28 days after receiving the submission on January 23, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K870265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1987 |
| Decision Date | February 20, 1987 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | KYB — Lens, Guide, Intraocular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |