Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K944548 |
Device Name |
REXPLUS PP3 |
Applicant |
REXTON, INC. |
2415 XENIUM LN. |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
DANIEL I ANDERSON |
Correspondent |
REXTON, INC. |
2415 XENIUM LN. |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
DANIEL I ANDERSON |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 09/16/1994 |
Decision Date | 11/14/1994 |
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
|
|
|