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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K010377
Device Name MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
Applicant
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325
Applicant Contact JENNIFER LYONS
Correspondent
MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE,  CA  91325
Correspondent Contact JENNIFER LYONS
Regulation Number880.6920
Classification Product Code
KZH  
Date Received02/08/2001
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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