GORE VIABIL BILILARY ENDOPROSTHESIS


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K081184
Device Name GORE VIABIL BILILARY ENDOPROSTHESIS
Applicant
W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV.
3250 west kiltie ln.
flagstaff, 
AZ 
86002 -0500

Applicant Contact michael ivey
Correspondent
W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV.
3250 west kiltie ln.
flagstaff, 
AZ 
86002 -0500

Correspodent Contact michael ivey
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 04/25/2008
Decision Date 07/22/2008
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