Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K963958 |
Device Name |
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT |
Applicant |
BELTONE ELECTRONICS CORP. |
4201 WEST VICTORIA ST. |
CHICAGO,
IL
60646
|
|
Applicant Contact |
ROBERT A KRATOCHVIL |
Correspondent |
BELTONE ELECTRONICS CORP. |
4201 WEST VICTORIA ST. |
CHICAGO,
IL
60646
|
|
Correspondent Contact |
ROBERT A KRATOCHVIL |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/02/1996 |
Decision Date | 12/05/1996 |
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
|
|
|