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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 K023308
Device Name LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT 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 Received10/03/2002
Decision Date 04/14/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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