Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K971745 |
Device Name |
BARD COMPOSITE PROSTHESIS |
Applicant |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
cranston,
RI
02920
|
|
Applicant Contact |
jeannette g cloutier |
Correspondent |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
cranston,
RI
02920
|
|
Correspondent Contact |
jeannette g cloutier |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/12/1997 |
Decision Date | 08/06/1997 |
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
|
|
|