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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
Device Name SURFLASH SAFETY I.V. CATHETER
Applicant
KOFU FACTORY OF TERUMO CORP.
950 ELKTON BLVD
ELKTON,  MD  21921
Applicant Contact PHILLIP LESTER
Correspondent
KOFU FACTORY OF TERUMO CORP.
950 ELKTON BLVD
ELKTON,  MD  21921
Correspondent Contact PHILLIP LESTER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/02/2014
Decision Date 05/30/2014
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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