Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K090858 |
Device Name |
PARIETEX MONOFILAMENT POLYESTER MESH |
Applicant |
SOFRADIM PRODUCTION |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
ANGELA BUNN |
Correspondent |
SOFRADIM PRODUCTION |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
ANGELA BUNN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/30/2009 |
Decision Date | 05/06/2009 |
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
|