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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 BK950019
Tradename DUPACO BLOOD/FLUID WARMING SET D25416
Device Name Device, Warming, Blood and Plasma
Original Applicant
DUPACO
2620 temple heights dr.
oceanside,  CA  92056
Regulation Number864.9205
Classification Product Code
KZL  
Date Received03/06/1995
Decision Date 04/27/1995
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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