The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Cold Soaker.
| Device ID | K910491 |
| 510k Number | K910491 |
| Device Name: | WALLACH COLD SOAKER |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Contact | Vincent Frazzetta |
| Correspondent | Vincent Frazzetta WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-05-21 |