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 |