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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord blood processing system and storage container
510(k) Number BK150314
Tradename Pall? Briostor? Transfer/Freezing Bag Set
Device Name Cord blood processing system and storage container
Original Applicant
Pall Corporation
25 harbor park drive
port washington,  NY  11050 4630
Regulation Number864.9900
Classification Product Code
OAO  
Date Received09/03/2015
Decision Date 06/16/2016
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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