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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 K964079
Device Name SPEEDBAND MULTIPLE BAND LIGATOR
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Applicant Contact LISA M QUAGLIA
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Correspondent Contact LISA M QUAGLIA
Regulation Number876.4400
Classification Product Code
FHN  
Subsequent Product Code
MND  
Date Received10/11/1996
Decision Date 02/13/1997
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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