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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 K211800
Device Name Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
Applicant
Quality in Flow Ltd.
11 Ha’avoda st.
Rosh Ha’ayin,  IL 4801761
Applicant Contact Omer Pechter
Correspondent
Quality in Flow Ltd.
11 Ha’avoda st.
Rosh Ha’ayin,  IL 4801761
Correspondent Contact Omer Pechter
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received06/10/2021
Decision Date 12/08/2022
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
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