| 510(k) Number |
K852559 |
| Device Name |
BONE PIN CUTTER-18 INCH |
| Applicant |
| The Huxley Instrument Corp. |
| 215 Main St. |
|
Penn Yan,
NY
14527
|
|
| Applicant Contact |
REBECCA J SHAHZADA |
| Correspondent |
| The Huxley Instrument Corp. |
| 215 Main St. |
|
Penn Yan,
NY
14527
|
|
| Correspondent Contact |
REBECCA J SHAHZADA |
| Date Received | 06/17/1985 |
| Decision Date | 07/02/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|