COLLAGEN DENTAL MEMBRANE

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 Membrane.

Pre-market Notification Details

Device IDK011695
510k NumberK011695
Device Name:COLLAGEN DENTAL MEMBRANE
ClassificationBarrier, Animal Source, Intraoral
Applicant COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,,  NJ  07417
ContactShu-tung Li
CorrespondentShu-tung Li
COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,,  NJ  07417
Product CodeNPL  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-31
Decision Date2001-08-07
Summary:summary

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