The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wa1000.
| Device ID | K813024 |
| 510k Number | K813024 |
| Device Name: | WA1000 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | WALLACH SURGICAL DEVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937019902 | K813024 | 000 |
| 00888937014037 | K813024 | 000 |
| 00888937014020 | K813024 | 000 |
| 00888937009873 | K813024 | 000 |
| 00888937009866 | K813024 | 000 |