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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 K120686
Device Name ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact KIM FONDA
Correspondent
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact KIM FONDA
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received03/06/2012
Decision Date 04/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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