CLEANCUT

Electrosurgical, Cutting & Coagulation & Accessories

MEDQUEST PRODUCTS, INC.

The following data is part of a premarket notification filed by Medquest Products, Inc. with the FDA for Cleancut.

Pre-market Notification Details

• Device ID: K972335
• 510k Number: K972335
• Device Name: CLEANCUT
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MEDQUEST PRODUCTS, INC. 825 NORTH, 300 WEST, SUITE NE 107 Salt Lake City, UT 84103 -1414
• Contact: Pratap S Khanwilkar
• Correspondent: Pratap S Khanwilkar; MEDQUEST PRODUCTS, INC. 825 NORTH, 300 WEST, SUITE NE 107 Salt Lake City, UT 84103 -1414
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-23
• Decision Date: 1999-01-07