Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K040998 |
Device Name |
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH |
Applicant |
SOFRADIM PRODUCTION |
5 WHITCOMB AVENUE |
AYER,
MA
01432
|
|
Applicant Contact |
MARY MCNAMARA-CULLINANE, RAC |
Correspondent |
SOFRADIM PRODUCTION |
5 WHITCOMB AVENUE |
AYER,
MA
01432
|
|
Correspondent Contact |
MARY MCNAMARA-CULLINANE, RAC |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/19/2004 |
Decision Date | 04/29/2004 |
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
|