K853063 is an FDA 510(k) clearance for the SMARTKNIFE SYSTEM. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).
Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on November 4, 1985, 108 days after receiving the submission on July 19, 1985.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K853063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 19, 1985 |
| Decision Date | November 04, 1985 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNN — Knife, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |