Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K974340 |
Device Name |
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE |
Applicant |
UNITRON INDUSTRIES, INC. |
3555 WALNUT ST. |
P.O. BOX 5010 |
PORT HURON,
MI
48061 -5010
|
|
Applicant Contact |
SUSAN ARCHER |
Correspondent |
UNITRON INDUSTRIES, INC. |
3555 WALNUT ST. |
P.O. BOX 5010 |
PORT HURON,
MI
48061 -5010
|
|
Correspondent Contact |
SUSAN ARCHER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 11/18/1997 |
Decision Date | 12/12/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|