Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K070644 |
Device Name |
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS |
Applicant |
W. L. GORE & ASSOCIATES, INC. |
301 AIRPORT RD. |
P.O. BOX 1408 |
ELKTON,
MD
21922 -1408
|
|
Applicant Contact |
BARBARA L SMITH |
Correspondent |
W. L. GORE & ASSOCIATES, INC. |
301 AIRPORT RD. |
P.O. BOX 1408 |
ELKTON,
MD
21922 -1408
|
|
Correspondent Contact |
BARBARA L SMITH |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/08/2007 |
Decision Date | 04/02/2007 |
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
|