| Device Classification Name |
Antiserum, Fluorescent, Francisella Tularensis
|
| 510(k) Number |
K914872 |
| Device Name |
MARLOW SUCTION/IRRIGATION PROBES |
| Applicant |
| Marlo Surgical Technology |
| 1810 Joseph Lloyd Pkwy. |
|
Willoughby,
OH
44094
|
|
| Applicant Contact |
SCOTT C MARLOW |
| Correspondent |
| Marlo Surgical Technology |
| 1810 Joseph Lloyd Pkwy. |
|
Willoughby,
OH
44094
|
|
| Correspondent Contact |
SCOTT C MARLOW |
| Regulation Number | 866.3280 |
| Classification Product Code |
|
| Date Received | 10/29/1991 |
| Decision Date | 11/19/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|