Device Classification Name |
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
|
510(k) Number |
K894478 |
Device Name |
UHMWPE SURGICAL MESH |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
LONNIE WITHAM |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
LONNIE WITHAM |
Regulation Number | 878.3500
|
Classification Product Code |
|
Date Received | 07/18/1989 |
Decision Date | 03/08/1990 |
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
|
|
|