| 510(k) Number |
K853016 |
| Device Name |
STILLE ANGULAR RONGEUR, 8-3/4 SS 410 |
| 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 | 07/17/1985 |
| Decision Date | 08/07/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|