Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K950319 |
Device Name |
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE |
Applicant |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
KRISTA M BUCKLES |
Correspondent |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
KRISTA M BUCKLES |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/26/1995 |
Decision Date | 02/08/1995 |
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
|
|
|