| Device Classification Name |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
|
| 510(k) Number |
K802281 |
| Device Name |
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC |
| Applicant |
| Sherwood Medical Co. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Sherwood Medical Co. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 868.5640 |
| Classification Product Code |
|
| Date Received | 09/19/1980 |
| Decision Date | 10/03/1980 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|