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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K143446
Device Name Accu-Chek FlexLink Plus infusion set
Applicant
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Applicant Contact Alexander Ruegner
Correspondent
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Correspondent Contact Alexander Ruegner
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/02/2014
Decision Date 08/13/2015
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
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