Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K900267 |
Device Name |
JAHN VENTILATION TUBE |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ROBERT F GAMES |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ROBERT F GAMES |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 01/18/1990 |
Decision Date | 06/14/1990 |
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
|
|
|