Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K062558 |
Device Name |
MESOSFOL SURGICAL FILM |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
ERIKA MARTIN |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
ERIKA MARTIN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/30/2006 |
Decision Date | 06/20/2007 |
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
|
|
|