| 510(k) Number |
K884630 |
| Device Name |
MULTI-PURPOSE HOLDER |
| Applicant |
| Med-Dex Intl. |
| Suite #237 |
| 4790 Irvine Blvd. #105 |
|
Irvine,
CA
92714
|
|
| Applicant Contact |
DIANE MOMODA-MADISON |
| Correspondent |
| Med-Dex Intl. |
| Suite #237 |
| 4790 Irvine Blvd. #105 |
|
Irvine,
CA
92714
|
|
| Correspondent Contact |
DIANE MOMODA-MADISON |
| Classification Product Code |
|
| Date Received | 11/07/1988 |
| Decision Date | 11/22/1988 |
| 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
|
|
|