| Device Classification Name |
Dilator, Nasal
|
| 510(k) Number |
K040491 |
| Device Name |
CHIN-UP STRIP |
| Applicant |
| Dale Miller, Inc. - the Chin-Up Company |
| 1820 Ridgemill Ter. |
|
Dracula,
GA
30019
|
|
| Applicant Contact |
DALE MILLER |
| Correspondent |
| Dale Miller, Inc. - the Chin-Up Company |
| 1820 Ridgemill Ter. |
|
Dracula,
GA
30019
|
|
| Correspondent Contact |
DALE MILLER |
| Regulation Number | 874.3900 |
| Classification Product Code |
|
| Date Received | 02/26/2004 |
| Decision Date | 09/10/2004 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ear Nose & Throat
|
| 510k Review Panel |
Ear Nose & Throat
|
| Statement |
Statement
|
| Type |
Abbreviated
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|