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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 K160592
Device Name SUPERCATH 6
Applicant
TOGO MEDIKIT CO., LTD.
17148-6 Aza Kamekawa, Oaza Hichiya
Hyuga City,  JP 883-0062
Applicant Contact Daisuke Nagamizu
Correspondent
MIC International
4-1-17 Hongo,
Bunkyo-ku,  JP 113-0033
Correspondent Contact Izumi Maruo
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/01/2016
Decision Date 08/12/2016
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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