| Device Classification Name |
Toothbrush, Powered
|
| 510(k) Number |
K920644 |
| Device Name |
F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND |
| Applicant |
| Fairform Mfg., Co., Ltd. |
| 5/F Shing King Indl. Bldg. |
| 206-208 Choi Hung Rd. |
|
San Po Kong, Kowloon,
HK
|
|
| Applicant Contact |
S. P WONG |
| Correspondent |
| Fairform Mfg., Co., Ltd. |
| 5/F Shing King Indl. Bldg. |
| 206-208 Choi Hung Rd. |
|
San Po Kong, Kowloon,
HK
|
|
| Correspondent Contact |
S. P WONG |
| Regulation Number | 872.6865 |
| Classification Product Code |
|
| Date Received | 02/12/1992 |
| Decision Date | 05/29/1992 |
| 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
|
|
|