Porcine Anorganic Bone Mineral In Delivery Applicator

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 Anorganic Bone Mineral In Delivery Applicator.

Pre-market Notification Details

Device IDK162158
510k NumberK162158
Device Name:Porcine Anorganic Bone Mineral In Delivery Applicator
ClassificationBone Grafting Material, Animal Source
Applicant Collagen Matrix, Inc. 15 Thornton Road Oakland,  NJ  07436
ContactPeggy Hansen
CorrespondentPeggy Hansen
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 Received2016-08-02
Decision Date2017-02-09
Summary:summary

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