K791763 is an FDA 510(k) clearance for the (MICRO-KERATRON, MICRO DUCT TREPHINE). This device is classified as a Engine, Trephine, Accessories, Ac-powered (Class I - General Controls, product code HRG).
Submitted by Intl. Ophthalmic Industries Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979, 61 days after receiving the submission on September 5, 1979.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4070.
| 510(k) Number | K791763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1979 |
| Decision Date | November 05, 1979 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HRG — Engine, Trephine, Accessories, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4070 |