Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K851213 |
Device Name |
ZWEYMULLER CUP |
Applicant |
ALLO PRO CORP. |
POST OFFICE BOX 14159 |
CLEARWATER,
FL
34279
|
|
Applicant Contact |
SYLVIA KAPLUN |
Correspondent |
ALLO PRO CORP. |
POST OFFICE BOX 14159 |
CLEARWATER,
FL
34279
|
|
Correspondent Contact |
SYLVIA KAPLUN |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 03/26/1985 |
Decision Date | 05/28/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|