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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 BK170002
Tradename 3C Patch System
Device Name Peripheral blood processing device for wound management
Original Applicant
Reapplix Aps
blokken 45
birkerod,  3460
Regulation Number864.9245
Classification Product Code
PMQ  
Date Received01/03/2017
Decision Date 04/04/2017
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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