HOFFMAN UNIVERSAL FOOT SUPPORT

Component, Traction, Non-invasive

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Hoffman Universal Foot Support.

Pre-market Notification Details

• Device ID: K821252
• 510k Number: K821252
• Device Name: HOFFMAN UNIVERSAL FOOT SUPPORT
• Classification: Component, Traction, Non-invasive
• Applicant: HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KQZ
• CFR Regulation Number: 888.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-04-30
• Decision Date: 1982-06-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327095067	K821252	000