Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K842637 |
Device Name |
UNIFLOW VENT TUBE |
Applicant |
RICHARDS MEDICAL CO., INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ROBERT F GAMES |
Correspondent |
RICHARDS MEDICAL CO., INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ROBERT F GAMES |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 07/09/1984 |
Decision Date | 10/25/1984 |
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
|
|
|