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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 K112290
Device Name SUPERCATH Z3V
Applicant
TOGO MEDIKIT CO., LTD.
4-1-17 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Applicant Contact FUMIAKI KANAI
Correspondent
TOGO MEDIKIT CO., LTD.
4-1-17 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Correspondent Contact FUMIAKI KANAI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/09/2011
Decision Date 04/16/2012
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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