K955083 is an FDA 510(k) clearance for the VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION). This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on February 8, 1996, 136 days after receiving the submission on September 25, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K955083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1995 |
| Decision Date | February 08, 1996 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEH - Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |