PuraDERM Gel

Dressing, Wound, Drug

3-D Matrix, Inc.

The following data is part of a premarket notification filed by 3-d Matrix, Inc. with the FDA for Puraderm Gel.

Pre-market Notification Details

Device IDK193085
510k NumberK193085
Device Name:PuraDERM Gel
ClassificationDressing, Wound, Drug
Applicant 3-D Matrix, Inc. 250 First Ave., Suite 205 Needham,  MA  02494
ContactLisa Spirio
CorrespondentStephen P. Rhodes
Streamline Regulatory 3502 Dundee Driveway Chevy Chase,  MD  20815
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-05
Decision Date2020-05-11

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