K871871 is an FDA 510(k) clearance for the SERIES TEN THOUSAND OCUTOME. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on June 11, 1987, 29 days after receiving the submission on May 13, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K871871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1987 |
| Decision Date | June 11, 1987 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |