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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 K993417
Device Name GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
Applicant
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Applicant Contact ROXANE BAXTER
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  CA  94538
Correspondent Contact ROXANE BAXTER
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received10/01/1999
Decision Date 01/21/2000
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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