Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K132441 |
Device Name |
BARD VENTRALEX HERNIA PATCH |
Applicant |
C.R. BARD, INC. |
100 CROSSINGS BLVD. |
WARWICK,
RI
02886
|
|
Applicant Contact |
MARIYA BUHARIN |
Correspondent |
C.R. BARD, INC. |
100 CROSSINGS BLVD. |
WARWICK,
RI
02886
|
|
Correspondent Contact |
MARIYA BUHARIN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/06/2013 |
Decision Date | 12/13/2013 |
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
|