| Device Classification Name |
Instrument, Manual, Surgical, General Use
|
| 510(k) Number |
K905478 |
| Device Name |
YANKAUER SUCTION DEVICE |
| Applicant |
| Medovations, Inc. |
| 102 E. Keefe Ave. |
|
Milwaukee,
WI
53212
|
|
| Applicant Contact |
BRIAN E LARSON |
| Correspondent |
| Medovations, Inc. |
| 102 E. Keefe Ave. |
|
Milwaukee,
WI
53212
|
|
| Correspondent Contact |
BRIAN E LARSON |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 12/06/1990 |
| Decision Date | 12/19/1990 |
| 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
|
|
|