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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K121504
Device Name SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
Applicant
TOGO MEDIKIT CO., LTD.
611 WEST 5TH STREET
AUSTIN,  TX  78701
Applicant Contact HEATHER CRAWFORD
Correspondent
TOGO MEDIKIT CO., LTD.
611 WEST 5TH STREET
AUSTIN,  TX  78701
Correspondent Contact HEATHER CRAWFORD
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/21/2012
Decision Date 09/27/2012
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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