Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K914449 |
Device Name |
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE |
Applicant |
W.L. GORE & ASSOCIATES,INC |
1505 NORTH FOURTH ST. |
FLAGSTAFF,
AZ
86003 -3000
|
|
Applicant Contact |
DAWN LOPEZ |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
1505 NORTH FOURTH ST. |
FLAGSTAFF,
AZ
86003 -3000
|
|
Correspondent Contact |
DAWN LOPEZ |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/04/1991 |
Decision Date | 12/04/1991 |
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
|
|
|