Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K043056 |
Device Name |
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
Applicant |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Applicant Contact |
BRANDON HANSON |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Correspondent Contact |
BRANDON HANSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/05/2004 |
Decision Date | 12/22/2004 |
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
|