BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

Dura Substitute

COOK BIOTECH, INC.

The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Biodesign Onlay Dural Graft Or Biodesign Duraplasty Graft.

Pre-market Notification Details

• Device ID: K131015
• 510k Number: K131015
• Device Name: BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
• Classification: Dura Substitute
• Applicant: COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906
• Contact: Mary A Faderan
• Correspondent: Mary A Faderan; COOK BIOTECH, INC. 1425 INNOVATION PLACE West Lafayette, IN 47906
• Product Code: GXQ
• CFR Regulation Number: 882.5910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-11
• Decision Date: 2013-10-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00827002349803	K131015	000
00827002349797	K131015	000
00827002349780	K131015	000
00827002349773	K131015	000