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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K141070
Device Name SUPER SHEATH
Applicant
Togo Medikit Co., Ltd.
4-1-17 Hongo
Bunkyo-Ku,  JP 113-0033
Applicant Contact IZUMI MARUO
Correspondent
Togo Medikit Co., Ltd.
4-1-17 Hongo
Bunkyo-Ku,  JP 113-0033
Correspondent Contact IZUMI MARUO
Regulation Number870.1310
Classification Product Code
DRE  
Subsequent Product Code
DYB  
Date Received04/25/2014
Decision Date 01/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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