K942897 is an FDA 510(k) clearance for the OPTHALMIC WIPE. This device is classified as a Frame, Spectacle (Class I — General Controls, product code HQZ).
Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on August 5, 1994, 46 days after receiving the submission on June 20, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5842.
| 510(k) Number | K942897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1994 |
| Decision Date | August 05, 1994 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQZ — Frame, Spectacle |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.5842 |