K823901 is an FDA 510(k) clearance for the TREPHINE BLADES-VARIOUS MODELS. This device is classified as a Engine, Trephine, Accessories, Ac-powered (Class I — General Controls, product code HRG).
Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1983, 18 days after receiving the submission on December 30, 1982.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4070.
| 510(k) Number | K823901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1982 |
| Decision Date | January 17, 1983 |
| Days to Decision | 18 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 |