Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K081777 |
Device Name |
VENTRIO HERNIA PATCH |
Applicant |
C.R. BARD, INC. |
100 CROSSINGS BLVD. |
WARWICK,
RI
02886
|
|
Applicant Contact |
STEPHANIE BAKER |
Correspondent |
C.R. BARD, INC. |
100 CROSSINGS BLVD. |
WARWICK,
RI
02886
|
|
Correspondent Contact |
STEPHANIE BAKER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/23/2008 |
Decision Date | 09/29/2008 |
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
|
|
|