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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 K253924
Device Name PuraStat
Applicant
3-D Matrix Europe SAS
11 Chemin Des Petites Brosses
2nd Floor
Caluire Et Cuire,  FR 69300
Applicant Contact Audrey Vion
Correspondent
3-D Matrix Europe SAS
11 Chemin Des Petites Brosses
2nd Floor
Caluire Et Cuire,  FR 69300
Correspondent Contact Audrey Vion
Regulation Number878.4456
Classification Product Code
QAU  
Date Received12/08/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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