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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 K123377
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 Received11/01/2012
Decision Date 11/30/2012
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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