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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 K172496
Device Name SUPERCATH 5 (26G)
Applicant
TOGO Medikit Co., Ltd.
17148-6 Aza Kamekawa
Oaza Hichiya
Hyuga City,  JP 883-0062
Applicant Contact Daisuke Nagamizu
Correspondent
TOGO Medikit Co., Ltd.
17148-6 Aza Kamekawa
Oaza Hichiya
Hyuga City,  JP 883-0062
Correspondent Contact Daisuke Nagamizu
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/18/2017
Decision Date 03/23/2018
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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