Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K173796 |
Device Name |
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) |
Applicant |
Sofradim Production |
116 avenue du Formans |
Trevoux,
FR
01600
|
|
Applicant Contact |
Benjamin Rochette |
Correspondent |
Coviden |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Angela Van Arsdale |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/14/2017 |
Decision Date | 03/09/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|