The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Quantum 500 Electrosurgical Generator.
| Device ID | K983208 |
| 510k Number | K983208 |
| Device Name: | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR |
| 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 | 1998-09-14 |
| Decision Date | 1999-02-22 |