Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K011460 |
Device Name |
WUJIN #3 TIBIAL BONE PLATE |
Applicant |
BIOPRO, INC. |
17 SEVENTEENTH ST. |
PORT HURON,
MI
48060
|
|
Applicant Contact |
PATRICK PRINGLE |
Correspondent |
BIOPRO, INC. |
17 SEVENTEENTH ST. |
PORT HURON,
MI
48060
|
|
Correspondent Contact |
PATRICK PRINGLE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/11/2001 |
Decision Date | 08/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|