| 510(k) Number |
K860506 |
| Device Name |
HARBOR MEDICAL RESPIRATORY TRAY |
| Applicant |
| Harbor Medical, Inc. |
| 929 Longdale Ave. |
|
Longwood,
FL
32750
|
|
| Applicant Contact |
GINGER TALLEY |
| Correspondent |
| Harbor Medical, Inc. |
| 929 Longdale Ave. |
|
Longwood,
FL
32750
|
|
| Correspondent Contact |
GINGER TALLEY |
| Date Received | 02/11/1986 |
| Decision Date | 03/10/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|