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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K083646
Device Name MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
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 Number882.5950
Classification Product Code
HCG  
Date Received12/09/2008
Decision Date 01/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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