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
10827002349800	K131015	000
10827002349794	K131015	000
10827002349787	K131015	000
10827002349770	K131015	000