| Device Classification Name |
Dilator, Nasal
|
| 510(k) Number |
K862406 |
| Device Name |
NOZEES NOSTRIL DILATOR |
| Applicant |
| Nozees Co. |
| 705 Edgewood Blvd. |
|
Omaha,
NE
68128
|
|
| Applicant Contact |
MACHADO |
| Correspondent |
| Nozees Co. |
| 705 Edgewood Blvd. |
|
Omaha,
NE
68128
|
|
| Correspondent Contact |
MACHADO |
| Regulation Number | 874.3900 |
| Classification Product Code |
|
| Date Received | 06/25/1986 |
| Decision Date | 09/19/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ear Nose & Throat
|
| 510k Review Panel |
Ear Nose & Throat
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|