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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name peripheral blood processing device for wound management
510(k) Number BK251232
Tradename PRF-Matrix System
Device Name Peripheral blood processing device for wound management
Original Applicant
Royal Wound-X, Inc.
401 hackensack ave.
suite 604
hackensack,  NJ  07061
Regulation Number864.9245
Classification Product Code
PMQ  
Date Received05/27/2025
Decision Date 02/20/2026
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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