Porcine Mineral Collagen Composite Moldable

Bone Grafting Material, Animal Source

Collagen Matrix, Inc.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Porcine Mineral Collagen Composite Moldable.

Pre-market Notification Details

Device IDK201859
510k NumberK201859
Device Name:Porcine Mineral Collagen Composite Moldable
ClassificationBone Grafting Material, Animal Source
Applicant Collagen Matrix, Inc. 15 Thornton Road Oakland,  NJ  07436
ContactGloria Zuclich
CorrespondentGloria Zuclich
Collagen Matrix, Inc. 15 Thornton Road Oakland,  NJ  07436
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2020-09-11

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