Cleared Traditional

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT

K131015 · Cook Biotech, Inc. · Neurology

Oct 2013

Decision

180d

Days

Class 2

Risk

About This 510(k) Submission

K131015 is an FDA 510(k) clearance for the BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Cook Biotech, Inc. (West Lafayetta, US). The FDA issued a Cleared decision on October 8, 2013, 180 days after receiving the submission on April 11, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number	K131015 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2013
Decision Date	October 08, 2013
Days to Decision	180 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF