MEDIFIL

Dressing, Wound, Collagen

BIOCORE

The following data is part of a premarket notification filed by Biocore with the FDA for Medifil.

Pre-market Notification Details

• Device ID: K910944
• 510k Number: K910944
• Device Name: MEDIFIL
• Classification: Dressing, Wound, Collagen
• Applicant: BIOCORE 7420 FALCON ST. Topeka, KS 66610
• Contact: Manoj K Jain
• Correspondent: Manoj K Jain; BIOCORE 7420 FALCON ST. Topeka, KS 66610
• Product Code: KGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-03-06
• Decision Date: 1991-04-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00324357090010	K910944	000
00618474000510	K910944	000