Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K081010 |
FOIA Releasable 510(k) |
K081010
|
Device Name |
BARD 3DMAX MESH |
Applicant |
DAVOL INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
cranston,
RI
02920
|
|
Applicant Contact |
stephanie baker |
Correspondent |
DAVOL INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
cranston,
RI
02920
|
|
Correspondent Contact |
stephanie baker |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/09/2008 |
Decision Date | 10/07/2008 |
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
|
|
|