Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K960219 |
Device Name |
PROLEX MESH |
Applicant |
ADVANCED SURGICAL INNOVATIONS, INC. |
6890 PACIFIC CIRCLE |
MISSISSAUGA, ONTARIO,
CA
L5TIN8
|
|
Applicant Contact |
DAVID M OLSEN |
Correspondent |
ADVANCED SURGICAL INNOVATIONS, INC. |
6890 PACIFIC CIRCLE |
MISSISSAUGA, ONTARIO,
CA
L5TIN8
|
|
Correspondent Contact |
DAVID M OLSEN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/16/1996 |
Decision Date | 03/15/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|