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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K052834
Device Name MREYE EMBOLIZATION COIL
Applicant
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact LISA M WEBB
Correspondent
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact LISA M WEBB
Regulation Number870.3300
Classification Product Code
KRD  
Date Received10/06/2005
Decision Date 11/23/2005
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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