The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Leep Procedure Kit.
| Device ID | K935634 |
| 510k Number | K935634 |
| Device Name: | WALLACH LEEP PROCEDURE KIT |
| Classification | Electrocautery, Gynecologic (and 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 | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937000041 | K935634 | 000 |