Device Classification Name |
Prosthesis, Hip, Femoral Component, Cemented, Metal
|
510(k) Number |
K931194 |
Device Name |
CO-CR ANSWER FEMORAL COMPONENT |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
DUTCH HARRISON |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
DUTCH HARRISON |
Regulation Number | 888.3360
|
Classification Product Code |
|
Date Received | 03/09/1993 |
Decision Date | 05/05/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|