| 510(k) Number |
K902813 |
| Device Name |
SHAVE PREP TRAY |
| Applicant |
| Orion Life Systems, Inc. |
| 124 Messner Dr. |
|
Wheeling,
IL
60090
|
|
| Applicant Contact |
JOHN L LAEMMAR |
| Correspondent |
| Orion Life Systems, Inc. |
| 124 Messner Dr. |
|
Wheeling,
IL
60090
|
|
| Correspondent Contact |
JOHN L LAEMMAR |
| Date Received | 06/27/1990 |
| Decision Date | 11/19/1990 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|