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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 K002181
Device Name GDC ULTRASOFT COIL
Applicant
Boston Scientific, Target
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact JAMES LEATHLEY
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact JAMES LEATHLEY
Regulation Number882.5950
Classification Product Code
HCG  
Date Received07/19/2000
Decision Date 08/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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