Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K896056 |
Device Name |
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID |
Applicant |
REXTON, INC. |
2415 XENIUM LN. |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
JOHN J ZEI |
Correspondent |
REXTON, INC. |
2415 XENIUM LN. |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
JOHN J ZEI |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/18/1989 |
Decision Date | 01/10/1990 |
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
|
|
|