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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 K010788
Device Name SIMPLICITY SOFT QD EASY INFUSION SET
Applicant
Sterling Medivations, Inc.
180 Ferndale Rd. S.
Wayzata,  MN  55391
Applicant Contact JOEL S DOUGLAS
Correspondent
Sterling Medivations, Inc.
180 Ferndale Rd. S.
Wayzata,  MN  55391
Correspondent Contact JOEL S DOUGLAS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/15/2001
Decision Date 04/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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