Collagen Dental Wound Dressings

Dressing, Wound, Collagen

COLLAGEN MATRIX, INC.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Wound Dressings.

Pre-market Notification Details

Device IDK152600
510k NumberK152600
Device Name:Collagen Dental Wound Dressings
ClassificationDressing, Wound, Collagen
Applicant COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland,  NJ  07436
ContactGloria Zuclich
CorrespondentGloria Zuclich
COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland,  NJ  07436
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-11
Decision Date2016-06-23
Summary:summary

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