Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K122436 |
Device Name |
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM |
Applicant |
C.R. BARD, INC. |
100 CROSSINGS BOULEVARD |
WARWICK,
RI
02886
|
|
Applicant Contact |
KETI SINO |
Correspondent |
C.R. BARD, INC. |
100 CROSSINGS BOULEVARD |
WARWICK,
RI
02886
|
|
Correspondent Contact |
KETI SINO |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/10/2012 |
Decision Date | 11/02/2012 |
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
|
Recalls |
CDRH Recalls
|