MODIFICATION TO VIABAHN ENDOPROSTHESIS


Device Classification Name

prosthesis, tracheal, expandable

510(k) Number K023811
Device Name MODIFICATION TO VIABAHN ENDOPROSTHESIS
Original Applicant
W.L. GORE & ASSOCIATES,INC
3750 west kiltie ln.
p.o. box 900
flagstaff, 
AZ 
86002 -0900

Original Contact timothy j rynn
Regulation Number 878.3720
Classification Product Code
JCT  
Date Received 11/15/2002
Decision Date 12/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No