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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK960083
Tradename Hematype Segment Device
Device Name Supplies, Blood-Bank
Original Applicant
Fenwal Inc
three corporate drive
lake zurich,  IL  60047
Regulation Number864.9050
Classification Product Code
KSS  
Date Received10/29/1996
Decision Date 02/28/1997
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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