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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 K173831
Device Name Glidesheath Slender
Applicant
Terumo Medical Corporation
950 Elkton Blvd
Elkton,  MD  21921
Applicant Contact Liang Lu
Correspondent
Terumo Medical Corporation
950 Elkton Blvd
Elkton,  MD  21921
Correspondent Contact Liang Lu
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/18/2017
Decision Date 05/08/2018
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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