| 510(k) Number |
K827963 |
| Device Name |
MODEL ML-850 |
| Applicant |
| Merrimack Laboratories |
| 34 Tower St. |
|
Hudson,
MA
01749
|
|
| Correspondent |
| Merrimack Laboratories |
| 34 Tower St. |
|
Hudson,
MA
01749
|
|
| Date Received | 08/20/1982 |
| Decision Date | 09/13/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|