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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 K171215
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
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received04/25/2017
Decision Date 09/27/2017
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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