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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 K040550
Device Name LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
Applicant
ORBUS MEDICAL TECHNOLOGIES
5363 N.W. 35TH AVE.
FT. LAUDERDALE,  FL  33309 -6315
Applicant Contact JIM CLOSSICK
Correspondent
ORBUS MEDICAL TECHNOLOGIES
5363 N.W. 35TH AVE.
FT. LAUDERDALE,  FL  33309 -6315
Correspondent Contact JIM CLOSSICK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/02/2004
Decision Date 03/16/2004
Decision SE - With Limitations (SESU)
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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