| 510(k) Number |
K851047 |
| Device Name |
PLASTIC TUBE EXTENTION SET |
| Applicant |
| Medovations, Inc. |
| 11311 W. Locust St. |
|
Wauwatosa,
WI
53222
|
|
| Applicant Contact |
SURY R SHONEY |
| Correspondent |
| Medovations, Inc. |
| 11311 W. Locust St. |
|
Wauwatosa,
WI
53222
|
|
| Correspondent Contact |
SURY R SHONEY |
| Date Received | 03/14/1985 |
| Decision Date | 04/25/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|