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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 K160860
Device Name MiniMed Quick-serter
Applicant
MEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE,  CA  91325
Applicant Contact Noreen Bajwa
Correspondent
MEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE,  CA  91325
Correspondent Contact Noreen Bajwa
Regulation Number880.6920
Classification Product Code
KZH  
Date Received03/29/2016
Decision Date 09/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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