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 | K000768 |
| 510k Number | K000768 |
| Device Name: | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| 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 | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-09 |
| Decision Date | 2000-04-11 |