Cleared Special

DURAGEN PLUS DURAL GRAFT MATRIX

K032693 · Integra Lifesciences Corp. · Neurology
Sep 2003
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K032693 is an FDA 510(k) clearance for the DURAGEN PLUS DURAL GRAFT MATRIX, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on September 30, 2003, 28 days after receiving the submission on September 2, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K032693 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2003
Decision Date September 30, 2003
Days to Decision 28 days
Submission Type Special
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