Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K113229 |
Device Name |
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING |
Applicant |
C.R. BARD, INC. |
100 CROSSINGS BOULEVARD |
WARWICK,
RI
02886
|
|
Applicant Contact |
STEPHANIE BAKER |
Correspondent |
C.R. BARD, INC. |
100 CROSSINGS BOULEVARD |
WARWICK,
RI
02886
|
|
Correspondent Contact |
STEPHANIE BAKER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/02/2011 |
Decision Date | 07/20/2012 |
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 |
Yes
|