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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 K103355
Device Name GDC 360 DETEACHABLE COIL
Applicant
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538 -6515
Applicant Contact RHODA M SANTOS
Correspondent
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538 -6515
Correspondent Contact RHODA M SANTOS
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received11/16/2010
Decision Date 02/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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