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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 K003283
Device Name SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
Applicant
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA,  MN  55391
Applicant Contact JOEL DOUGLAS
Correspondent
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA,  MN  55391
Correspondent Contact JOEL DOUGLAS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/19/2000
Decision Date 12/13/2000
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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