| Device Classification Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
| 510(k) Number |
K843081 |
| Device Name |
TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT |
| Applicant |
| Creative Medical Laboratories, Inc. |
| P.O. Box 6347 |
|
|
|
| Applicant Contact |
ALLEN W MOBERG |
| Correspondent |
| Creative Medical Laboratories, Inc. |
| P.O. Box 6347 |
|
|
|
| Correspondent Contact |
ALLEN W MOBERG |
| Regulation Number | 878.4780 |
| Classification Product Code |
|
| Date Received | 08/06/1984 |
| Decision Date | 10/11/1984 |
| 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
|