K760763 is an FDA 510(k) clearance for the COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I. This device is classified as a Colposcope (and Colpomicroscope) (Class II - Special Controls, product code HEX).
Submitted by Dynatech Cryomedical Co. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1976, 16 days after receiving the submission on October 4, 1976.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1630.
| 510(k) Number | K760763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1976 |
| Decision Date | October 20, 1976 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HEX — Colposcope (and Colpomicroscope) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1630 |