The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Ultra Freeze.
| Device ID | K935010 |
| 510k Number | K935010 |
| Device Name: | WALLACH ULTRA FREEZE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Contact | Raymond A Wiley |
| Correspondent | Raymond A Wiley 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 | 1993-10-20 |
| Decision Date | 1994-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937010961 | K935010 | 000 |
| 00888937010015 | K935010 | 000 |
| 00888937010008 | K935010 | 000 |
| 00888937009996 | K935010 | 000 |
| 00888937009989 | K935010 | 000 |
| 00888937009781 | K935010 | 000 |
| 00888937009774 | K935010 | 000 |
| 00888937009767 | K935010 | 000 |
| 00888937009750 | K935010 | 000 |