K903878 is an FDA 510(k) clearance for the MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT. This device is classified as a Apparatus, Cautery, Radiofrequency, Battery-powered (Class II - Special Controls, product code HQQ).
Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on November 5, 1990, 75 days after receiving the submission on August 22, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100.
| 510(k) Number | K903878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1990 |
| Decision Date | November 05, 1990 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQQ — Apparatus, Cautery, Radiofrequency, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4100 |