Device Classification Name |
Mesh, Surgical, Absorbable, Abdominal Hernia
|
510(k) Number |
K033671 |
FOIA Releasable 510(k) |
K033671
|
Device Name |
GORE BIOABSORBABLE MESH |
Applicant |
W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
BRANDON HANSEN |
Correspondent |
W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
BRANDON HANSEN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/24/2003 |
Decision Date | 12/31/2003 |
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
|
|
|