Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K002684 |
Device Name |
COMPOSIX E/X MESH |
Applicant |
C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CANSTON,
RI
02920
|
|
Applicant Contact |
RUTH C FORSTADT |
Correspondent |
C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
CANSTON,
RI
02920
|
|
Correspondent Contact |
RUTH C FORSTADT |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/28/2000 |
Decision Date | 10/11/2000 |
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
|
|
|