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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K122590
Device Name RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
Applicant
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Applicant Contact STACY A KLUESNER, MS, RAC
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact STACY A KLUESNER, MS, RAC
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/24/2012
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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