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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 BK980021
Tradename Cord-X System
Device Name Container, Empty, For the Collection '& Processing of Blood/Blood Components
Original Applicant
Talon Medical, Ltd.
18160 highway 281 n
suite 108
san antonio,  TX  78232
Regulation Number864.9100
Classification Product Code
KSR  
Date Received07/23/1998
Decision Date 01/20/1999
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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