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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 K112385
Device Name TRAGET DETACHABLE COIL
Applicant
STRYKER NEUROVASCULAR
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Applicant Contact JAMES LEATHLEY
Correspondent
STRYKER NEUROVASCULAR
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Correspondent Contact JAMES LEATHLEY
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/18/2011
Decision Date 09/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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