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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
Model VARIOUS CATALOG NUMBERS
Device Name ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
Original Applicant
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham,  MA  02767 0350
Original 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 (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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