Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K951642 |
Device Name |
GOLD CD ULTRA MINI CANAL - MODULE |
Applicant |
ELECTONE, INC. |
1124 FLORIDA CENTRAL PKWY. |
LONGWOOD,
FL
32750
|
|
Applicant Contact |
JIM NEE |
Correspondent |
ELECTONE, INC. |
1124 FLORIDA CENTRAL PKWY. |
LONGWOOD,
FL
32750
|
|
Correspondent Contact |
JIM NEE |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 04/10/1995 |
Decision Date | 07/11/1995 |
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
|
|
|