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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K192860
Device Name Sapphire Infusion Pump, Sapphire administration sets
Applicant
Q Core Medical Ltd.
29 Yad Haruzim St.
Netanya,  IL 4250529
Applicant Contact Guy Mlechkovich
Correspondent
Z & B Enterprises, Inc.
12154 Darnestown Road, #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MRZ  
Date Received10/04/2019
Decision Date 11/19/2020
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
Recalls CDRH Recalls
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