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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, transfer (blood/plasma)
510(k) Number BK170004
Tradename Charter Medical Cell Therapy Fluid Transfer Set
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Charter Medical, Ltd.
3948-a westpoint blvd.
winston-salem,  NC  27103
Regulation Number864.9875
Classification Product Code
KSB  
Date Received01/13/2017
Decision Date 10/06/2017
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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