| 510(k) Number |
K902410 |
| Device Name |
MEDICAL PROCEDURE TRAY |
| Applicant |
| Sorex Medical |
| 5725 W. Harold Gatty Dr. |
|
Salt Lake City,
UT
84116
|
|
| Applicant Contact |
JOSEPH SORENSON |
| Correspondent |
| Sorex Medical |
| 5725 W. Harold Gatty Dr. |
|
Salt Lake City,
UT
84116
|
|
| Correspondent Contact |
JOSEPH SORENSON |
| Classification Product Code |
|
| Date Received | 05/31/1990 |
| Decision Date | 11/20/1990 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|