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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 BK860023
Tradename Level 1 Fluid Warmer
Device Name Device, Warming, Blood and Plasma
Original Applicant
Level 1 Technologies, Inc.
160 weymouth street
rockland,  MA  02370
Regulation Number864.9205
Classification Product Code
Date Received05/08/1986
Decision Date 09/25/1986
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