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 |