K853631 is an FDA 510(k) clearance for the POLY-SLEEVE..
Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on November 1, 1985, 63 days after receiving the submission on August 30, 1985.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K853631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1985 |
| Decision Date | November 01, 1985 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | — |
| Device Class | — |