Device Classification Name |
Face Plate Hearing Aid
|
510(k) Number |
K862768 |
Device Name |
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 |
Applicant |
MAICO HEARING INSTRUMENTS, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2029
|
|
Applicant Contact |
PAUL M D'AMICO |
Correspondent |
MAICO HEARING INSTRUMENTS, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2029
|
|
Correspondent Contact |
PAUL M D'AMICO |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/22/1986 |
Decision Date | 08/13/1986 |
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
|
|
|