Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K881193 |
Device Name |
ACCUTONE IN-THE-EAR HEARING AID |
Applicant |
INTERSTATE HEARING AID SERVICE |
15 PUBLIC SQUARE |
WILKES BARRE,
PA
18701
|
|
Applicant Contact |
JAMES CULP |
Correspondent |
INTERSTATE HEARING AID SERVICE |
15 PUBLIC SQUARE |
WILKES BARRE,
PA
18701
|
|
Correspondent Contact |
JAMES CULP |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/21/1988 |
Decision Date | 05/18/1988 |
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
|
|
|