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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 K171491
Device Name R2P Destination Slender Guiding Sheath
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 Received05/22/2017
Decision Date 10/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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