| Device Classification Name |
Toothbrush, Powered
|
| 510(k) Number |
K942634 |
| Device Name |
PEMBUSH |
| Applicant |
| Crossroads Trading Co. |
| 257 Cloydon Cir. |
|
Montecito,
CA
93108
|
|
| Applicant Contact |
DOUGLAS A TRIGG |
| Correspondent |
| Crossroads Trading Co. |
| 257 Cloydon Cir. |
|
Montecito,
CA
93108
|
|
| Correspondent Contact |
DOUGLAS A TRIGG |
| Regulation Number | 872.6865 |
| Classification Product Code |
|
| Date Received | 06/03/1994 |
| Decision Date | 09/02/1994 |
| 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
|
|
|