Hemostatic Device For Endoscopic Gastrointestinal Use

3-D Matrix, Inc.

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

Pre-market Notification Details

Device IDK210098
510k NumberK210098
Device Name:PuraStat-GI
ClassificationHemostatic Device For Endoscopic Gastrointestinal Use
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 CodeQAU  
CFR Regulation Number878.4456 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-14
Decision Date2021-06-25

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