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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 K113412
Device Name TARGET DETACHABLE COIL
Original Applicant
STRYKER NEUROVASCULAR
47900 bayside parkway
fremont,  CA  94538 6515
Original Contact rhoda santos
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received11/18/2011
Decision Date 12/13/2011
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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