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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 K052557
Device Name SUPER SHEATH INTRODUCER SHEATH
Applicant
TOGO MEDIKIT CO., LTD.
5905 NATHAN LANE
MAIL STOP P-25
PLYMOUTH,  MN  55442
Applicant Contact HEIDI M ERICKSON
Correspondent
TOGO MEDIKIT CO., LTD.
5905 NATHAN LANE
MAIL STOP P-25
PLYMOUTH,  MN  55442
Correspondent Contact HEIDI M ERICKSON
Regulation Number870.1310
Classification Product Code
DRE  
Date Received09/16/2005
Decision Date 01/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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