Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K903472 |
Device Name |
BEST LABS MODEL M |
Applicant |
BEST LABS |
P.O. BOX 20468 |
ST. PETERSBURG,
FL
33742
|
|
Applicant Contact |
HARVEY ROMANEK |
Correspondent |
BEST LABS |
P.O. BOX 20468 |
ST. PETERSBURG,
FL
33742
|
|
Correspondent Contact |
HARVEY ROMANEK |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/31/1990 |
Decision Date | 11/09/1990 |
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
|
|
|