Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K223218 |
Device Name |
Parietene Macroporous Mesh |
Applicant |
Sofradim Production |
116 Avenue du Formans |
Trevoux,
FR
01600
|
|
Applicant Contact |
Jhony Mallet |
Correspondent |
Covidien |
15 Hampshire Street |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Wing Ng |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/17/2022 |
Decision Date | 12/02/2022 |
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
|