Device Classification Name |
mesh, surgical, polymeric
|
510(k) Number |
K181268 |
Device Name |
PROLENE (Polypropylene) 3D Patch |
Applicant |
Ethicon, Inc. |
Route 22 West |
P.O Box 151 |
Somerville,
NJ
08876 -0151
|
|
Applicant Contact |
Melina Escobar |
Correspondent |
Ethicon, Inc. |
Route 22 West |
P.O Box 151 |
Somerville,
NJ
08876 -0151
|
|
Correspondent Contact |
Melina Escobar |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 05/14/2018 |
Decision Date | 07/26/2018 |
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
|