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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Esophageal
510(k) Number K990864
Device Name SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact ABBY LIPMAN
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact ABBY LIPMAN
Regulation Number876.4400
Classification Product Code
MND  
Date Received03/16/1999
Decision Date 06/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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