Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K960741 |
Device Name |
COMFORTONE PHS |
Applicant |
COMFORTONE AMERICA'S VALUE HEARING AID LINE |
851 NORTH WEST ST. |
WICHITA,
KS
67203
|
|
Applicant Contact |
PAUL ROARK |
Correspondent |
COMFORTONE AMERICA'S VALUE HEARING AID LINE |
851 NORTH WEST ST. |
WICHITA,
KS
67203
|
|
Correspondent Contact |
PAUL ROARK |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 02/23/1996 |
Decision Date | 05/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|