The following data is part of a premarket notification filed by Cryosurgery, Inc. with the FDA for Verruca-freeze(tm) Cryosurgical Delivery Syst, Modified.
| Device ID | K944221 |
| 510k Number | K944221 |
| Device Name: | VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED |
| 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 | 1994-08-15 |
| Decision Date | 1994-12-15 |