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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 K192325
Device Name Quantum Blood and Fluid Warming System
Applicant
Life Warmer, Inc.
4813 Keller Springs Rd
Addison,  TX  75001
Applicant Contact John Pettini
Correspondent
Life Warmer, Inc.
4813 Keller Springs Rd
Addison,  TX  75001
Correspondent Contact John Pettini
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received08/27/2019
Decision Date 10/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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