WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM

Electrocautery, Gynecologic (and Accessories)

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Quantum 2000 Electrosurgical System.

Pre-market Notification Details

• Device ID: K963653
• 510k Number: K963653
• Device Name: WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
• Classification: Electrocautery, Gynecologic (and Accessories)
• Applicant: WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460
• Contact: Raymond A Wiley
• Correspondent: Raymond A Wiley; WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460
• Product Code: HGI
• CFR Regulation Number: 884.4120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-12
• Decision Date: 1997-06-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
60888937011380	K963653	000
00888937019926	K963653	000
00888937014235	K963653	000
00888937013993	K963653	000