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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number BK940062
Tradename Cryocyte TM
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Baxter Healthcare Corporation
1 baxter pkwy.
deerfield,  IL  60015
Regulation Number864.9100
Classification Product Code
KSR  
Date Received10/06/1994
Decision Date 12/27/1994
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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