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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
Applicant
STRYKER NEUROVASCULAR
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Applicant Contact RHODA SANTOS
Correspondent
STRYKER NEUROVASCULAR
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Correspondent 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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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