Device Classification Name |
Bit, Drill
|
510(k) Number |
K870217 |
Device Name |
FEMORAL CEMENT REMOVAL INSTRUMENTS |
Applicant |
KENNETH J. HOEK, M.D., INC. |
620 S. DORA |
UKIAH,
CA
95482
|
|
Correspondent |
KENNETH J. HOEK, M.D., INC. |
620 S. DORA |
UKIAH,
CA
95482
|
|
Regulation Number | 888.4540
|
Classification Product Code |
|
Date Received | 01/21/1987 |
Decision Date | 02/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|