Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K934917 |
Device Name |
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION |
Applicant |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
JEANNETTE SELOOVER |
Correspondent |
RESOUND CORP. |
220 SAGINAW DRIVE, |
SEAPORT CENTRE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
JEANNETTE SELOOVER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/13/1993 |
Decision Date | 01/19/1995 |
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
|
|
|