Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K791126 |
Device Name |
MODEL CE-DM-II HEARING INSTRUMENT |
Applicant |
MARCON HEARING INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MARCON HEARING INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/18/1979 |
Decision Date | 07/17/1979 |
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
|
|
|