Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K150091 |
Device Name |
Versatex Monofilament Mesh |
Applicant |
SOFRADIM PRODUCTION |
116 AVENUE DU FORMANS |
TREVOUX,
FR
01600
|
|
Applicant Contact |
Benjamin Rochette |
Correspondent |
COVIDIEN(Surgical Solutions) |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Mary Mellows |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/16/2015 |
Decision Date | 05/26/2015 |
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
|