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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 BK090020
Tradename CryoMACS Freezing Bag
Device Name Container, Frozen Donor Tissue Storage
Original Applicant
Miltenyi Biotec, Inc.
120 presidential way
suite 305
woburn,  MA  01801
Classification Product Code
LPZ  
Date Received04/27/2009
Decision Date 01/13/2010
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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