Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K933644 |
Device Name |
WIDEX MODEL LOGO 8 (L8) |
Applicant |
WIDEX HEARING AID CO., INC. |
35-53 24TH ST. |
LONG ISLAND CITY,
NY
11106
|
|
Applicant Contact |
RON MELTSNER |
Correspondent |
WIDEX HEARING AID CO., INC. |
35-53 24TH ST. |
LONG ISLAND CITY,
NY
11106
|
|
Correspondent Contact |
RON MELTSNER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/27/1993 |
Decision Date | 08/23/1993 |
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
|
|
|