Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K922708 |
Device Name |
WIDEX MODEL D32 |
Applicant |
WIDEX HEARING AID CO., INC. |
35-23 24TH ST. |
LONG ISLAND CITY,
NY
11106
|
|
Applicant Contact |
RON MELTSNR |
Correspondent |
WIDEX HEARING AID CO., INC. |
35-23 24TH ST. |
LONG ISLAND CITY,
NY
11106
|
|
Correspondent Contact |
RON MELTSNR |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/05/1992 |
Decision Date | 06/30/1992 |
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
|
Recalls |
CDRH Recalls
|
|
|