Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K142908 |
Device Name |
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh |
Applicant |
SOFRADIM PRODUCTION |
116 AVENUE DU FORMANS |
TREVOUX,
FR
01600
|
|
Applicant Contact |
Eric Jague |
Correspondent |
Surgical devices, a global business unit of Covidien |
60 Middleton Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Mary Mellows |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/06/2014 |
Decision Date | 11/14/2014 |
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
|
Recalls |
CDRH Recalls
|