Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K960680 |
Device Name |
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 |
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 | 02/20/1996 |
Decision Date | 04/10/1996 |
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
|
|
|