Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K882692 |
Device Name |
MODEL P20/P21 IN-THE-EAR HEARING AID |
Applicant |
MAICO HEARING INSTRUMENTS, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2029
|
|
Applicant Contact |
DUANE SMEDSRUD |
Correspondent |
MAICO HEARING INSTRUMENTS, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439 -2029
|
|
Correspondent Contact |
DUANE SMEDSRUD |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/28/1988 |
Decision Date | 07/15/1988 |
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
|
|
|