The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Quantum 500 Electrosurgical Generator (proposed).
| Device ID | K983840 |
| 510k Number | K983840 |
| Device Name: | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) |
| Classification | Electrocautery, Gynecologic (and 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 | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-05-20 |
| Summary: | summary |