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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 K900904
Device Name CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
Applicant
CANDELA LASER CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact GEORGE CHO
Correspondent
CANDELA LASER CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact GEORGE CHO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/27/1990
Decision Date 05/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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