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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 K142429
Device Name CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham,  MA  02767
Applicant Contact Hannah Foley
Codman & Shurtleff, Inc
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Hannah Foley
Regulation Number882.5950
Classification Product Code
Subsequent Product Code
Date Received08/29/2014
Decision Date 12/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No