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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 K050114
Device Name SUPERCATH Z3V
Applicant
TOGO MEDIKIT CO., LTD.
17148-6 AZA KAMEKAWA
OAZA HICHIYA
HYUGA CITY, MIYAZAKI PREF.,  JP 883-0062
Applicant Contact KOZO NAGAYAMAB
Correspondent
TOGO MEDIKIT CO., LTD.
17148-6 AZA KAMEKAWA
OAZA HICHIYA
HYUGA CITY, MIYAZAKI PREF.,  JP 883-0062
Correspondent Contact KOZO NAGAYAMAB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/18/2005
Decision Date 06/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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