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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K052267
Device Name SUPERCATH V
Applicant
Togo Medikit Co., Ltd.
4-2-1 Yushima
Bunkyo-Ku
Tokyo,  JP 113-0034
Applicant Contact FUMIAKI KANAI
Correspondent
Togo Medikit Co., Ltd.
4-2-1 Yushima
Bunkyo-Ku
Tokyo,  JP 113-0034
Correspondent Contact FUMIAKI KANAI
Regulation Number876.5540
Classification Product Code
FIE  
Date Received08/19/2005
Decision Date 10/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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