LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K023308
Device Name LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS 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 10/03/2002
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