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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 BK210570
Tradename RD2 Ver.02 System
Device Name Peripheral blood processing device for wound management
Original Applicant
RedDress Ltd
shkedim street 11
pardes hanna,  370110, 
Regulation Number864.9245
Classification Product Code
PMQ  
Date Received03/24/2021
Decision Date 06/22/2021
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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