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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 K193160
Device Name Glidesheath Slender Tibial Pedal Kit
Applicant
Terumo Medical Coporation
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact Liang Lu
Correspondent
Terumo Medical Coporation
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact Liang Lu
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/15/2019
Decision Date 12/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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