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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 K122686
Device Name ACCU-CHEK ULTRAFLEX INFUSION SET
Original Applicant
ROCHE DIABETES CARE AG
kirchbergstrasse 190
burgdorf,  CH ch-3401
Original Contact catherine green
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/04/2012
Decision Date 11/16/2012
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
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