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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 K022427
Device Name CONTOUR SE MICROSPHERES
Applicant
BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK
GLENS FALLS,  NY  12801 -3864
Applicant Contact JODI LYNN GREENIZEN
Correspondent
BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK
GLENS FALLS,  NY  12801 -3864
Correspondent Contact JODI LYNN GREENIZEN
Regulation Number882.5950
Classification Product Code
HCG  
Date Received07/25/2002
Decision Date 08/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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