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 IDK122115
510k NumberK122115
Device Name:COLLAGEN DENTAL WOUND DRESSINGS
ClassificationDressing, Wound, Collagen
Applicant COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland,  NJ  07436
ContactPeggy Hansen
CorrespondentPeggy Hansen
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 Received2012-07-17
Decision Date2012-11-01
Summary:summary

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