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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 K141389
FOIA Releasable 510(k) K141389
Device Name SAPPHIRE INFUSION PUMP
Applicant
Q CORE MEDICAL LTD
12154 DARNESTOWN ROAD
#236
GAITHERSBURG,  MD  20878
Applicant Contact Rhona Shanker
Correspondent
Q CORE MEDICAL LTD
12154 DARNESTOWN ROAD
#236
GAITHERSBURG,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received05/27/2014
Decision Date 12/11/2014
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
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