| 510(k) Number |
K930884 |
| Device Name |
MEDICAL PROCEDURE TRAY, MODIFICATION |
| Applicant |
| Enpak Medical Corp. |
| 2440 S. Progress Dr. |
|
Salt Lake City,
UT
84119
|
|
| Applicant Contact |
SCOTT CRAWFORD |
| Correspondent |
| Enpak Medical Corp. |
| 2440 S. Progress Dr. |
|
Salt Lake City,
UT
84119
|
|
| Correspondent Contact |
SCOTT CRAWFORD |
| Classification Product Code |
|
| Date Received | 02/17/1993 |
| Decision Date | 03/21/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| 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
|
|
|