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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 K122544
Device Name TERUMO SURFLASH SAFETY I.V. CATHETER
Applicant
TERUMO Corporation
1727-1, TSUIJIARAI, SHOWA-CHO
NAKAKOMA-GUN
YAMANASHI,  JP 409-3853
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 Received08/21/2012
Decision Date 09/05/2012
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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