| Device Classification Name |
Handpiece, Air-Powered, Dental
|
| 510(k) Number |
K911068 |
| Device Name |
29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM |
| Applicant |
| Micro Motors, Inc. |
| 151 E. Columbine Ave. |
|
Santa Ana,
CA
92707
|
|
| Applicant Contact |
RUSS REINSCH |
| Correspondent |
| Micro Motors, Inc. |
| 151 E. Columbine Ave. |
|
Santa Ana,
CA
92707
|
|
| Correspondent Contact |
RUSS REINSCH |
| Regulation Number | 872.4200 |
| Classification Product Code |
|
| Date Received | 03/11/1991 |
| Decision Date | 05/15/1991 |
| 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
|
|
|