Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K142091 |
Device Name |
PARIETENE MACROPOROUS MESH |
Applicant |
SOFRADIM PRODUCTION |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
JENNIFER BRENNAN |
Correspondent |
SOFRADIM PRODUCTION |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
JENNIFER BRENNAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/01/2014 |
Decision Date | 10/17/2014 |
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
|