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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 DK760012
Tradename Blood Warmer, Code 4R4305
Device Name Blood and Plasma Warming Devices
Original Applicant
Travenol Laboratories
rt 120 and wilson rd.
round lake,  IL  60073
Regulation Number864.9205
Classification Product Code
Date Received06/10/1976
Decision Date 07/16/1976
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