Device Classification Name |
mesh, surgical
|
510(k) Number |
K030782 |
Device Name |
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
Applicant |
W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
MIKE JOHNSON |
Correspondent |
W. L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LN. |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
MIKE JOHNSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/11/2003 |
Decision Date | 04/21/2003 |
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
|
|
|