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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K152525
FOIA Releasable 510(k) K152525
Device Name TR BAND Radial Compression Device
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 Number870.4450
Classification Product Code
DXC  
Date Received09/03/2015
Decision Date 11/10/2015
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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