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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, frozen donor tissue storage
510(k) Number BK100049
Tradename Cell-Freeze® Cryogenic Storage Container
Device Name Container, Frozen Donor Tissue Storage
Original Applicant
Charter Medical, Ltd.
3948-a westpoint blvd.
winston-salem,  NC  27103
Classification Product Code
LPZ  
Date Received07/22/2010
Decision Date 12/07/2010
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
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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