PROFLEX

Arthroscope

UTAH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Proflex.

Pre-market Notification Details

• Device ID: K821672
• 510k Number: K821672
• Device Name: PROFLEX
• Classification: Arthroscope
• Applicant: UTAH MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-06-09
• Decision Date: 1982-07-22