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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 K093681
Device Name MERIDIAN GUIDEWIRE
Applicant
Ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Applicant Contact DEBORAH BAKER-JANIS
Correspondent
Ev3 Neurovascular
9775 Toledo Way
Lrvine,  CA  92618
Correspondent Contact DEBORAH BAKER-JANIS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/27/2009
Decision Date 01/26/2010
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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