Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K141560 |
Device Name |
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE |
Applicant |
ETHICON, INC. |
P.O. BOX 151 |
ROUTE 22 WEST |
somerville,
NJ
08876 -0151
|
|
Applicant Contact |
susan lin |
Correspondent |
ETHICON, INC. |
P.O. BOX 151 |
ROUTE 22 WEST |
somerville,
NJ
08876 -0151
|
|
Correspondent Contact |
susan lin |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/12/2014 |
Decision Date | 10/23/2014 |
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
|