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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 K253017
Device Name BloodSTOP iX Trauma Matrix (TM-iX-20)
Applicant
Lifescience Plus, Inc.
2520a Wyandotte St.
Mountain View,  CA  94043
Applicant Contact Audrey Vitale
Correspondent
Lifescience Plus, Inc.
2520a Wyandotte St.
Mountain View,  CA  94043
Correspondent Contact Audrey Vitale
Classification Product Code
QSY  
Date Received09/19/2025
Decision Date 04/30/2026
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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