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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 K042539
Device Name GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
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  
Date Received09/20/2004
Decision Date 10/19/2004
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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