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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 K123712
Device Name RETRACTA DETACHABLE EMBOLIZATION COIL
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Applicant Contact JENNIFER RICHARDSON
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Correspondent Contact JENNIFER RICHARDSON
Regulation Number870.3300
Classification Product Code
KRD  
Date Received12/04/2012
Decision Date 01/03/2013
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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