K760742 is an FDA 510(k) clearance for the CS-76 AND/OR CRYOCARE I. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Frigitronics of Connecticut, Inc. (Walker, US). The FDA issued a Cleared decision on November 3, 1976, 34 days after receiving the submission on September 30, 1976.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K760742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1976 |
| Decision Date | November 03, 1976 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |