Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K033814 |
Device Name |
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 |
Applicant |
C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Applicant Contact |
SUZANNE LASCALZA |
Correspondent |
C.R. BARD, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Correspondent Contact |
SUZANNE LASCALZA |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/09/2003 |
Decision Date | 03/01/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|