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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K013104
Device Name SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
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 Number880.5440
Classification Product Code
FPA  
Date Received09/17/2001
Decision Date 10/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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