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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 K093142
Device Name TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Applicant Contact JAMES LEATHLEY
Correspondent
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Correspondent Contact JAMES LEATHLEY
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received10/05/2009
Decision Date 02/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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