Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K140501 |
Device Name |
XENMATRIX SURGICAL GRAFT |
Applicant |
C.R. BARD |
100 CROSSINGS BOULEVARD |
WARWICK,
RI
02886
|
|
Applicant Contact |
GINA CASSIDY |
Correspondent |
C.R. BARD |
100 CROSSINGS BOULEVARD |
WARWICK,
RI
02886
|
|
Correspondent Contact |
GINA CASSIDY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/27/2014 |
Decision Date | 04/28/2014 |
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
|
|
|