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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK060004
Tradename Promote Platelet Rich Concentrate (PRC) Preparation System
Device Name Blood Bank Supplies
Original Applicant
Smith & Nephew
1450 brooks road
memphis,  TN  38116
Regulation Number864.9050
Classification Product Code
KSS  
Date Received01/19/2006
Decision Date 05/02/2006
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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