HEMADERM

Dressing, Wound, Drug

MEDAFOR, INC.

The following data is part of a premarket notification filed by Medafor, Inc. with the FDA for Hemaderm.

Pre-market Notification Details

• Device ID: K033666
• 510k Number: K033666
• Device Name: HEMADERM
• Classification: Dressing, Wound, Drug
• Applicant: MEDAFOR, INC. 2700 FREEWAY BLVD SUITE 800 Minneapolis, MN 55430
• Contact: Jennifer A May
• Correspondent: Jennifer A May; MEDAFOR, INC. 2700 FREEWAY BLVD SUITE 800 Minneapolis, MN 55430
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-21
• Decision Date: 2003-12-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10801741044080	K033666	000