The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Loop Electrode.
| Device ID | K020711 |
| 510k Number | K020711 |
| Device Name: | WALLACH LOOP ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange, CT 06477 |
| Contact | Michael Malis |
| Correspondent | Michael Malis WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange, CT 06477 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-05 |
| Decision Date | 2002-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937009419 | K020711 | 000 |
| 20888937009297 | K020711 | 000 |
| 20888937009303 | K020711 | 000 |
| 00888937009316 | K020711 | 000 |
| 20888937009327 | K020711 | 000 |
| 20888937009334 | K020711 | 000 |
| 20888937009341 | K020711 | 000 |
| 20888937009358 | K020711 | 000 |
| 20888937009365 | K020711 | 000 |
| 20888937009372 | K020711 | 000 |
| 20888937009389 | K020711 | 000 |
| 20888937009396 | K020711 | 000 |
| 20888937009402 | K020711 | 000 |
| 20888937009280 | K020711 | 000 |