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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 K093546
Device Name SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
Applicant
TOGO MEDIKIT CO., LTD.
4-1-17 HONGO, BUNKYO-KU
TOKYO,  JP 113-0033
Applicant Contact FUMIAKI KANAI, PH.D
Correspondent
TOGO MEDIKIT CO., LTD.
4-1-17 HONGO, BUNKYO-KU
TOKYO,  JP 113-0033
Correspondent Contact FUMIAKI KANAI, PH.D
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/17/2009
Decision Date 12/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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