| Device Classification Name |
Handpiece, Air-Powered, Dental
|
| 510(k) Number |
K896878 |
| Device Name |
HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) |
| Applicant |
| Micro Motors, Inc. |
| 26941 Cabot Rd. |
| Suite 128 |
|
Laguna Hills,
CA
92653
|
|
| Applicant Contact |
CHARLES H NEWMAN |
| Correspondent |
| Micro Motors, Inc. |
| 26941 Cabot Rd. |
| Suite 128 |
|
Laguna Hills,
CA
92653
|
|
| Correspondent Contact |
CHARLES H NEWMAN |
| Regulation Number | 872.4200 |
| Classification Product Code |
|
| Date Received | 12/08/1989 |
| Decision Date | 03/08/1990 |
| 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
|
|
|