Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K970828 |
Device Name |
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER |
Applicant |
UNITED HEARING SYSTEMS, INC. |
731-B NORWICH RD. |
PLAINFIELD,
CT
06374
|
|
Applicant Contact |
RALPH CAMPAGNA |
Correspondent |
UNITED HEARING SYSTEMS, INC. |
731-B NORWICH RD. |
PLAINFIELD,
CT
06374
|
|
Correspondent Contact |
RALPH CAMPAGNA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/06/1997 |
Decision Date | 05/28/1997 |
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
|
|
|