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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 K102672
Device Name TARGET DETACHABLE COIL
Applicant
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538 -6515
Applicant Contact JAMES LEATHLEY
Correspondent
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538 -6515
Correspondent Contact JAMES LEATHLEY
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received09/16/2010
Decision Date 10/15/2010
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
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