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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 K013767
Device Name SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
Applicant
STERLING MEDIVATIONS, INC.
25285 LA LOMA DR.
LOS ALTOS HILLS,  CA  94022 -4583
Applicant Contact JOEL DOUGLAS
Correspondent
STERLING MEDIVATIONS, INC.
25285 LA LOMA DR.
LOS ALTOS HILLS,  CA  94022 -4583
Correspondent Contact JOEL DOUGLAS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/13/2001
Decision Date 12/12/2001
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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