K982506 is an FDA 510(k) clearance for the VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on January 27, 1999, 191 days after receiving the submission on July 20, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K982506 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 20, 1998 |
| Decision Date | January 27, 1999 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4350 |