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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K100704
Device Name ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
Applicant
DISETRONIC MEDICAL SYSTEMS AG
9115 Hague Road
Indianapolis,  IN  46250 -0457
Applicant Contact Scott Thiel
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
9115 Hague Road
Indianapolis,  IN  46250 -0457
Correspondent Contact Scott Thiel
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/12/2010
Decision Date 05/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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