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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K181775
Device Name Quantum Blood and IV Fluid Infusion Warmer
Applicant
Life Warmer, Inc.
840 F. Avenue Suite 104
Plano,  TX  75074
Applicant Contact John Pettini
Correspondent
Life Warmer, Inc.
840 F. Avenue Suite 104
Plano,  TX  75074
Correspondent Contact John Pettini
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received07/03/2018
Decision Date 01/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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