| Device Classification Name |
Tray, Surgical
|
| 510(k) Number |
K873290 |
| Device Name |
LACERATION AND INSTRUMENT TRAYS |
| Applicant |
| Advantage Medical Systems, Inc. |
| 905 Sheehy Dr. |
|
Horsham,
PA
19044
|
|
| Applicant Contact |
JOEL A MARCUS |
| Correspondent |
| Advantage Medical Systems, Inc. |
| 905 Sheehy Dr. |
|
Horsham,
PA
19044
|
|
| Correspondent Contact |
JOEL A MARCUS |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 08/17/1987 |
| Decision Date | 09/24/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 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
|
|
|