Cleared Traditional

COLLAGEN DURA MEMBRANE

K141608 · Collagen Matrix, Inc. · Neurology
Jan 2015
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K141608 is an FDA 510(k) clearance for the COLLAGEN DURA MEMBRANE, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on January 16, 2015, 214 days after receiving the submission on June 16, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K141608 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2014
Decision Date January 16, 2015
Days to Decision 214 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910