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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 K180154
Device Name QiF Blood and Fluid Warmer
Applicant
Quality IN Flow , Ltd.
Kibutz Einat
Pob 29
Kibutz Einat,  IL 4880500
Applicant Contact Neta Sherman
Correspondent
Quality IN Flow , Ltd.
Kibutz Einat
Pob 29
Kibutz Einat,  IL 4880500
Correspondent Contact Neta Sherman
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received01/19/2018
Decision Date 04/27/2018
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
Predetermined Change
Control Plan Authorized		 No
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