The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Leap 100 Electro Surgery System.
| Device ID | K921791 |
| 510k Number | K921791 |
| Device Name: | WALLACH LEAP 100 ELECTRO SURGERY SYSTEM |
| Classification | Electrocautery, Gynecologic (and 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 | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1995-05-04 |