Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K971298 |
Device Name |
BETTER HEARING, INC. MODEL L-1 HEARING AID |
Applicant |
BETTER HEARING, INC. |
112 ELDEN ST. |
HERNDON,
VA
20170 -4809
|
|
Applicant Contact |
LOUIS T GNECCO |
Correspondent |
BETTER HEARING, INC. |
112 ELDEN ST. |
HERNDON,
VA
20170 -4809
|
|
Correspondent Contact |
LOUIS T GNECCO |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 04/07/1997 |
Decision Date | 07/23/1997 |
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
|
|
|