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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K970052
Device Name EXTRACTORRX
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 Number876.5010
Classification Product Code
FGE  
Date Received01/07/1997
Decision Date 03/25/1997
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
Recalls CDRH Recalls
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