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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, blood, non-electromagnetic radiation
510(k) Number BK020043
Tradename level 1 fluid warming system
Device Name Warmer, Blood, Non-electromagnetic Radiation
Original Applicant
Level 1 Technologies, Inc.
160 weymouth street
rockland,  MA  02370
Regulation Number864.9205
Classification Product Code
BSB  
Date Received10/11/2002
Decision Date 06/16/2003
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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