Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K923887 |
Device Name |
JACK'S VENT TUBES |
Applicant |
O.R. SPECIALTIES, INC. |
4749 APPLETREE LN. |
TUSCALOOSA,
AL
35405
|
|
Applicant Contact |
JACK W HOWARD |
Correspondent |
O.R. SPECIALTIES, INC. |
4749 APPLETREE LN. |
TUSCALOOSA,
AL
35405
|
|
Correspondent Contact |
JACK W HOWARD |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 08/04/1992 |
Decision Date | 02/19/1993 |
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
|
|
|