The following data is part of a premarket notification filed by Cryosurgery, Inc. with the FDA for Verruca-freeze Cryosurgical Delivery System (modification).
| Device ID | K955083 |
| 510k Number | K955083 |
| Device Name: | VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOSURGERY, INC. P.O.BOX 50035 Nashville, TN 37205 -0035 |
| Contact | Ronald A Mcdow |
| Correspondent | Ronald A Mcdow CRYOSURGERY, INC. P.O.BOX 50035 Nashville, TN 37205 -0035 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1996-02-08 |