Device Classification Name |
Prosthesis, Tracheal, Expandable
|
510(k) Number |
K024178 |
Device Name |
VIATORR ENDOPROSTHESIS |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
JACQUELINE KALBACH |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JACQUELINE KALBACH |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 12/18/2002 |
Decision Date | 03/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|