LIFESTENT BILIARY ENDOPROSTHESIS


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K023121
Device Name LIFESTENT BILIARY ENDOPROSTHESIS
Original Applicant
ORBUS MEDICAL TECHNOLOGIES
5363 n.w. 35th ave.
ft. lauderdale, 
FL 
33309 -6315

Original Contact jim clossick
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 09/19/2002
Decision Date 03/10/2003
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