Device Classification Name |
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
|
510(k) Number |
K001789 |
Device Name |
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
Applicant |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
FLAGSTAFF,,
AZ
86002
|
|
Applicant Contact |
R. LARRY PRATT |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
3450 WEST KILTIE LN. |
FLAGSTAFF,,
AZ
86002
|
|
Correspondent Contact |
R. LARRY PRATT |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/13/2000 |
Decision Date | 07/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|