Oral Wound Dressing

3-D Matrix, Inc.

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

Pre-market Notification Details

Device IDK210211
510k NumberK210211
Device Name:PuraStat-OM
ClassificationOral Wound Dressing
Applicant 3-D Matrix, Inc. 1234 Chestnut St., Suite 205 Newton,  MA  02464
ContactLisa Spirio
CorrespondentStephen P. Rhodes
Streamline Regulatory 3502 Dundee Driveway Chevy Chase,  MD  20815
Product CodeOLR  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-27
Decision Date2021-10-08

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