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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 K250319
Device Name MFUSE (MS001)
Applicant
Machina Medical, Inc.
3055 Bellingrath Blvd.
Roswell,  GA  30076
Applicant Contact Tiffini Wittwer
Correspondent
Machina Medical, Inc.
3055 Bellingrath Blvd.
Roswell,  GA  30076
Correspondent Contact Tiffini Wittwer
Classification Product Code
QSY  
Date Received02/04/2025
Decision Date 12/15/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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