COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN

Barrier, Animal Source, Intraoral

COLLAGEN MATRIX, INC.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Mambrane - Porcine Type I Collagen.

Pre-market Notification Details

Device IDK110600
510k NumberK110600
Device Name:COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
ClassificationBarrier, Animal Source, Intraoral
Applicant COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland,  NJ  07436
ContactPeggy Hansen
CorrespondentPeggy Hansen
COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland,  NJ  07436
Product CodeNPL  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-02
Decision Date2011-07-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841336112056 K110600 000
00841336112049 K110600 000
00841336112032 K110600 000

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