Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K943960 |
Device Name |
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS |
Applicant |
MIRACLE-EAR, INC. |
4101 DAHLBERG DR. |
GOLDEN VALLEY,
MN
55422
|
|
Applicant Contact |
MELANIE RASKA |
Correspondent |
MIRACLE-EAR, INC. |
4101 DAHLBERG DR. |
GOLDEN VALLEY,
MN
55422
|
|
Correspondent Contact |
MELANIE RASKA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/15/1994 |
Decision Date | 10/20/1994 |
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
|
|
|