Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K021736 |
Device Name |
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 |
Applicant |
C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CANSTON,
RI
02920
|
|
Applicant Contact |
BRAIN A KANERVIKO |
Correspondent |
C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CANSTON,
RI
02920
|
|
Correspondent Contact |
BRAIN A KANERVIKO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/28/2002 |
Decision Date | 07/16/2002 |
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
|
|
|