SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX

Bone Grafting Material, Synthetic

COLLAGEN MATRIX, INC.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Synoss Collagen Synthetic Mineral-collagen Bone Graft Matrix.

Pre-market Notification Details

Device IDK083742
510k NumberK083742
Device Name:SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
ClassificationBone Grafting Material, Synthetic
Applicant COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,  NJ  07417
ContactPeggy Hansen
CorrespondentPeggy Hansen
COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,  NJ  07417
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-16
Decision Date2009-02-12
Summary:summary

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