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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 K010373
Device Name SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
Applicant
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA,  MN  55391
Applicant Contact JOEL DOUGLASS
Correspondent
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA,  MN  55391
Correspondent Contact JOEL DOUGLASS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/07/2001
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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