Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K032168 |
Device Name |
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL |
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 |
|
Date Received | 07/16/2003 |
Decision Date | 08/15/2003 |
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 |
Yes
|