| 510(k) Number |
K850320 |
| Device Name |
NEBULIZER TREATMENT KIT |
| Applicant |
| Dhd Medical Products Div. Diemolding Corp. |
| Division Of Diemolding Corp. |
|
Canastota,
NY
13032
|
|
| Applicant Contact |
RONALD N MCHENRY |
| Correspondent |
| Dhd Medical Products Div. Diemolding Corp. |
| Division Of Diemolding Corp. |
|
Canastota,
NY
13032
|
|
| Correspondent Contact |
RONALD N MCHENRY |
| Date Received | 01/28/1985 |
| Decision Date | 03/05/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|