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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
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