Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K912399 |
Device Name |
HEARING AID (ALL-IN-THE-EAR) |
Applicant |
CARLSON'S HERITAGE HEARING AID CENTER |
3004 NORTH ST. |
ANDERSON,
CA
96007
|
|
Applicant Contact |
NORMAN R CARLSON |
Correspondent |
CARLSON'S HERITAGE HEARING AID CENTER |
3004 NORTH ST. |
ANDERSON,
CA
96007
|
|
Correspondent Contact |
NORMAN R CARLSON |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/30/1991 |
Decision Date | 03/12/1992 |
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
|
|
|