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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Hemorrhoidal
510(k) Number K020824
Device Name SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,,  MA  01760 -1537
Applicant Contact KATHLEEN MORAHAN
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,,  MA  01760 -1537
Correspondent Contact KATHLEEN MORAHAN
Regulation Number876.4400
Classification Product Code
FHN  
Subsequent Product Code
MND  
Date Received03/14/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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