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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 K102818
Device Name MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
Applicant
Micrus Endovascular Corporation
821 Fox Lane
San Jose,  CA  95131
Applicant Contact PATRICK LEE
Correspondent
Micrus Endovascular Corporation
821 Fox Lane
San Jose,  CA  95131
Correspondent Contact PATRICK LEE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/28/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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