Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K101197 |
Device Name |
PARIE TENE PROGRIP MESH |
Applicant |
SOFRADIM PRODUCTION |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
SHARON ALEXANDER |
Correspondent |
SOFRADIM PRODUCTION |
60 MIDDLETOWN AVENUE |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
SHARON ALEXANDER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/28/2010 |
Decision Date | 05/05/2010 |
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
|