| Device Classification Name |
Tube, Tympanostomy
|
| 510(k) Number |
K904592 |
| Device Name |
BOBBIN STYLE VENTURI |
| Applicant |
| River Medical, Inc. |
| P.O.Box 30517 |
|
Memphis,
TN
38130
|
|
| Applicant Contact |
W MURRAY |
| Correspondent |
| River Medical, Inc. |
| P.O.Box 30517 |
|
Memphis,
TN
38130
|
|
| Correspondent Contact |
W MURRAY |
| Regulation Number | 874.3880 |
| Classification Product Code |
|
| Date Received | 10/10/1990 |
| Decision Date | 01/28/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ear Nose & Throat
|
| 510k Review Panel |
Ear Nose & Throat
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|