Device Classification Name |
Otoscope
|
510(k) Number |
K896274 |
Device Name |
TYMPANOSCOPE |
Applicant |
JEDMED INSTRUMENT CO. |
1430 HANLEY INDUSTRIAL CT. |
ST. LOUIS,
MO
63144
|
|
Applicant Contact |
CRAIG RAPP |
Correspondent |
JEDMED INSTRUMENT CO. |
1430 HANLEY INDUSTRIAL CT. |
ST. LOUIS,
MO
63144
|
|
Correspondent Contact |
CRAIG RAPP |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 10/30/1989 |
Decision Date | 01/26/1990 |
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
|
|
|