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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 K063146
Device Name ACCU-CHEK LINKASSIST
Applicant
DISETRONIC MEDICAL SYSTEMS AG
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Scott Thiel
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Scott Thiel
Regulation Number880.6920
Classification Product Code
KZH  
Date Received10/16/2006
Decision Date 11/27/2006
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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