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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK960075
Tradename Alton Dean Fluid Warmer, FW-537
Device Name Device, Warming, Blood and Plasma
Original Applicant
Mallinckrodt Medical, Inc.
675 mcdonnell boulevard
st. louis,  MO  63134
Regulation Number864.9205
Classification Product Code
KZL  
Date Received10/15/1996
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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