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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K072526
Device Name MICRUS COURIER ENZO MICROCATHETER 0.0190
Applicant
MICRUS ENDOVASCULAR CORPORATION
821 FOX LANE
SAN JOSE,  CA  95131
Applicant Contact MICHAEL CROMPTON
Correspondent
MICRUS ENDOVASCULAR CORPORATION
821 FOX LANE
SAN JOSE,  CA  95131
Correspondent Contact MICHAEL CROMPTON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/07/2007
Decision Date 10/05/2007
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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