Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K850413 |
Device Name |
MEC HIP BOLT |
Applicant |
PFIZER, INC. |
235 E 42ND ST. |
NY,
NY
10017
|
|
Applicant Contact |
BARBARA G RAMSEYER |
Correspondent |
PFIZER, INC. |
235 E 42ND ST. |
NY,
NY
10017
|
|
Correspondent Contact |
BARBARA G RAMSEYER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 02/04/1985 |
Decision Date | 07/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|