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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemostatic device for endoscopic gastrointestinal use
510(k) Number K210098
Device Name PuraStat-GI
Applicant
3-D Matrix, Inc.
1234 Chestnut St., Suite 205
Newton,  MA  02464
Applicant Contact Lisa Spirio
Correspondent
Streamline Regulatory
3502 Dundee Driveway
Chevy Chase,  MD  20815
Correspondent Contact Stephen P. Rhodes
Regulation Number878.4456
Classification Product Code
QAU  
Date Received01/14/2021
Decision Date 06/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02833558
Reviewed by Third Party No
Combination Product No
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