| Device Classification Name |
Unit, Oral Irrigation
|
| 510(k) Number |
K900547 |
| Device Name |
WATER PIK(R) W/ADD'L CLAIMS |
| Applicant |
| Teledyne Water Pik |
| 1730 E. Prospect Rd. |
|
Fort Collins,
CO
80525
|
|
| Applicant Contact |
W RUEHMANN |
| Correspondent |
| Teledyne Water Pik |
| 1730 E. Prospect Rd. |
|
Fort Collins,
CO
80525
|
|
| Correspondent Contact |
W RUEHMANN |
| Regulation Number | 872.6510 |
| Classification Product Code |
|
| Date Received | 02/05/1990 |
| Decision Date | 06/15/1990 |
| 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
|
|
|