Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K942107 |
Device Name |
MAGIC EAR, ELAIN |
Applicant |
NOVAPLEX, INC. |
8818 BRADLEY AVE. |
SUN VALLEY,
CA
91352
|
|
Applicant Contact |
WILLIAM PREVOST |
Correspondent |
NOVAPLEX, INC. |
8818 BRADLEY AVE. |
SUN VALLEY,
CA
91352
|
|
Correspondent Contact |
WILLIAM PREVOST |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/02/1994 |
Decision Date | 02/08/1995 |
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
|
|
|