Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K892898 |
Device Name |
ASTRO BEHIND-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 | 04/20/1989 |
Decision Date | 08/08/1989 |
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
|
|
|