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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 K981669
Device Name SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact LISA M QUAGLIA
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact LISA M QUAGLIA
Regulation Number876.4400
Classification Product Code
FHN  
Subsequent Product Code
MND  
Date Received05/12/1998
Decision Date 06/04/1998
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
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