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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 Rd.
Indianapolis,,  IN  46250 -0457
Applicant Contact Scott Thiel
Correspondent
Disetronic Medical Systems AG
9115 Hague Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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