CLEAN AIR

Powered Laser Surgical Instrument

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Clean Air.

Pre-market Notification Details

• Device ID: K943201
• 510k Number: K943201
• Device Name: CLEAN AIR
• Classification: Powered Laser Surgical Instrument
• Applicant: WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460
• Contact: Raymond Wiley
• Correspondent: Raymond Wiley; WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-05
• Decision Date: 1995-02-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50888937011185	K943201	000
00888937013986	K943201	000