| Device Classification Name |
General Surgery Tray
|
| 510(k) Number |
K932217 |
| Device Name |
MAJOR, MINOR, BASIN TRAYS (PACKS) |
| Applicant |
| Associated Medical Products Co. |
| 3250 Gorham Ave. |
|
St. Louis Park,
MN
55426
|
|
| Applicant Contact |
SCOTT WEISS |
| Correspondent |
| Associated Medical Products Co. |
| 3250 Gorham Ave. |
|
St. Louis Park,
MN
55426
|
|
| Correspondent Contact |
SCOTT WEISS |
| Regulation Number | 878.4370 |
| Classification Product Code |
|
| Date Received | 05/07/1993 |
| Decision Date | 11/15/1993 |
| Decision |
Substantially Equivalent - Kit
(SESK) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|