| Device Classification Name |
File, Pulp Canal, Endodontic
|
| 510(k) Number |
K870177 |
| Device Name |
ENDOBRUSH |
| Applicant |
| C & S Microinstruments , Ltd. |
| 110 Riviera Dr. #7, Markham |
|
Ontario, L3r 5m1,
CA
|
|
| Applicant Contact |
HAROLD WODLINGER,PHD |
| Correspondent |
| C & S Microinstruments , Ltd. |
| 110 Riviera Dr. #7, Markham |
|
Ontario, L3r 5m1,
CA
|
|
| Correspondent Contact |
HAROLD WODLINGER,PHD |
| Regulation Number | 872.4565 |
| Classification Product Code |
|
| Date Received | 01/15/1987 |
| Decision Date | 02/19/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|