Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K853325 |
Device Name |
DAHLBERG EC BEHIND-THE-EAR HEARING AID |
Applicant |
MIRACLE-EAR/DAHLBERG, INC. |
7731 COUNTRY CLUB DR. |
GOLDEN VALLEY,
MN
55427
|
|
Applicant Contact |
JANE E HIXSON |
Correspondent |
MIRACLE-EAR/DAHLBERG, INC. |
7731 COUNTRY CLUB DR. |
GOLDEN VALLEY,
MN
55427
|
|
Correspondent Contact |
JANE E HIXSON |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/08/1985 |
Decision Date | 09/23/1985 |
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
|
|
|