Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K930542 |
Device Name |
HEARING AID (ALL-IN-THE-EAR) |
Applicant |
ACTION LABS, INC. |
P.O. BOX 2195 |
INDEPENDENCE,
MO
64055
|
|
Applicant Contact |
RON TOLES |
Correspondent |
ACTION LABS, INC. |
P.O. BOX 2195 |
INDEPENDENCE,
MO
64055
|
|
Correspondent Contact |
RON TOLES |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 02/02/1993 |
Decision Date | 04/07/1993 |
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
|
|
|