| Device Classification Name |
Needle, Hypodermic, Single Lumen
|
| 510(k) Number |
K942624 |
| Device Name |
LOK-ON NEEDLE DISPOSAL CONTAINER |
| Applicant |
| Medical Safety Products, Inc. |
| 2751 W. Oxford Ave. #5 |
|
Englewood,
CO
80110
|
|
| Applicant Contact |
WILLLIAM E SAGSTETTER |
| Correspondent |
| Medical Safety Products, Inc. |
| 2751 W. Oxford Ave. #5 |
|
Englewood,
CO
80110
|
|
| Correspondent Contact |
WILLLIAM E SAGSTETTER |
| Regulation Number | 880.5570 |
| Classification Product Code |
|
| Date Received | 06/01/1994 |
| Decision Date | 08/25/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|