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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 Pkwy.
Fremont,  CA  94538 -6515
Applicant Contact RHODA SANTOS
Correspondent
Stryker Neurovascular
47900 Bayside Pkwy.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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