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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 K123267
Device Name SURFFLASH(R) PLUS SAFETY I.V. CATHETER
Applicant
KOFU FACTORY OF TERUMO CORP.
950 ELKTON BLVD
ELKTON,  MD  21921
Applicant Contact SANDI HARTKA
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/19/2012
Decision Date 11/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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