| 510(k) Number |
K853061 |
| Device Name |
MST MODEL #ARLG-5 |
| Applicant |
| Marlo Surgical Technology |
| 1810 Joseph Lloyd Pkwy. |
|
Willoughby,
OH
44094
|
|
| Applicant Contact |
SCOTT MARLOW |
| Correspondent |
| Marlo Surgical Technology |
| 1810 Joseph Lloyd Pkwy. |
|
Willoughby,
OH
44094
|
|
| Correspondent Contact |
SCOTT MARLOW |
| Date Received | 07/19/1985 |
| Decision Date | 09/04/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|