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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 K122856
Device Name CHARTER GUIDEWIRE
Applicant
Brivant, Ltd.
Parkmore W. Business Park
Galway,  IE EI
Applicant Contact KENNETH WALSH
Correspondent
Brivant, Ltd.
Parkmore W. Business Park
Galway,  IE EI
Correspondent Contact KENNETH WALSH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/18/2012
Decision Date 10/17/2012
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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