| 510(k) Number |
K853463 |
| Device Name |
LX EMBEDDING CENTER |
| Applicant |
| Innovative Medical Systems, Inc. |
| 55 Steamwhistle Dr. |
|
Ivyland,
PA
18974
|
|
| Applicant Contact |
JOSEPH CATARIOUS |
| Correspondent |
| Innovative Medical Systems, Inc. |
| 55 Steamwhistle Dr. |
|
Ivyland,
PA
18974
|
|
| Correspondent Contact |
JOSEPH CATARIOUS |
| Date Received | 08/19/1985 |
| Decision Date | 08/28/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Pathology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|