Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K923226 |
Device Name |
EURION LOTOS PP HEARING AID |
Applicant |
EURION HEARING INSTRUMENTS |
P.O. BOX 8816 |
GRAND RAPIDS,
MI
49518
|
|
Applicant Contact |
ROBERT A CUNNINGHAM |
Correspondent |
EURION HEARING INSTRUMENTS |
P.O. BOX 8816 |
GRAND RAPIDS,
MI
49518
|
|
Correspondent Contact |
ROBERT A CUNNINGHAM |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/01/1992 |
Decision Date | 07/30/1992 |
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
|
|
|