Device Classification Name |
mesh, surgical
|
510(k) Number |
K011027 |
Device Name |
FORTAFLEX SURGICAL SLING |
Applicant |
ORGANOGENESIS, INC. |
150 DAN RD. |
CANTON,
MA
02021
|
|
Applicant Contact |
PATRICK R BILBO |
Correspondent |
ORGANOGENESIS, INC. |
150 DAN RD. |
CANTON,
MA
02021
|
|
Correspondent Contact |
PATRICK R BILBO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/05/2001 |
Decision Date | 05/30/2001 |
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
|
|
|