E-Z CLEAN

Electrosurgical, Cutting & Coagulation & Accessories

AMERICAN MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for E-z Clean.

Pre-market Notification Details

• Device ID: K862221
• 510k Number: K862221
• Device Name: E-Z CLEAN
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: AMERICAN MEDICAL PRODUCTS, INC. 9690 SOUTH 1300 EAST Sandy, UT 84070
• Contact: Richard W Baggett
• Correspondent: Richard W Baggett; AMERICAN MEDICAL PRODUCTS, INC. 9690 SOUTH 1300 EAST Sandy, UT 84070
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-06-11
• Decision Date: 1986-09-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30614559101289	K862221	000
30614559100589	K862221	000