Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K861532 |
Device Name |
RX-33S INTRA MINI CANAL MODULE |
Applicant |
REXTON, INC. |
768 FOSTER AVE. |
BENSENVILLE,
IL
60106
|
|
Applicant Contact |
THOMAS O YATES |
Correspondent |
REXTON, INC. |
768 FOSTER AVE. |
BENSENVILLE,
IL
60106
|
|
Correspondent Contact |
THOMAS O YATES |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 04/24/1986 |
Decision Date | 06/05/1986 |
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
|
|
|