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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 K991139
Device Name GUGLIELMI DETACHABLE (GDC)
Applicant
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact JIM LEATHLEY
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact JIM LEATHLEY
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received04/05/1999
Decision Date 12/22/1999
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
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