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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 K070189
Device Name ACCU-CHEK ULTRAFLEX INFUSION SET
Applicant
DISETRONIC MEDICAL SYSTEMS AG
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact MIKE FLIS
Correspondent
DISETRONIC MEDICAL SYSTEMS AG
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact MIKE FLIS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/22/2007
Decision Date 02/21/2007
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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