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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 K140419
Device Name SUPERCATH5
Applicant
TOGO MEDIKIT CO., LTD.
4-1-17 HONGO
BUNKYO-KU,  JP 113-0033
Applicant Contact IZUMI MARUO
Correspondent
TOGO MEDIKIT CO., LTD.
4-1-17 HONGO
BUNKYO-KU,  JP 113-0033
Correspondent Contact IZUMI MARUO
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/18/2014
Decision Date 05/12/2014
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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