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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K253609
Device Name TRAUMAGEL® 2.0 Hemostatic Gel
Applicant
Cresilon, Inc.
86 34th St.
Suite D603/D604
Brooklyn,  NY  11232
Applicant Contact Hassaan Ahmad
Correspondent
Cresilon, Inc.
86 34th St.
Suite D603/D604
Brooklyn,  NY  11232
Correspondent Contact Hassaan Ahmad
Classification Product Code
QSY  
Date Received11/18/2025
Decision Date 12/12/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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