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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter,intravascular,therapeutic,short-term less than 30 days
510(k) Number K141138
Models C10014, C10016, C10X16
Device Name SURFLASH SAFETY I.V. CATHETER
Original Applicant
KOFU FACTORY OF TERUMO CORP.
950 elkton blvd
elkton,  MD  21921
Original Contact phillip lester
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/02/2014
Decision Date 05/30/2014
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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