Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K864277 |
Device Name |
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS |
Applicant |
UNIMAX HEARING INSTRUMENTS |
1622 WEST UNIVERSITY DR. |
P.O. BOX 782 |
DENTON,
TX
76202
|
|
Applicant Contact |
MAX CHARTRAND |
Correspondent |
UNIMAX HEARING INSTRUMENTS |
1622 WEST UNIVERSITY DR. |
P.O. BOX 782 |
DENTON,
TX
76202
|
|
Correspondent Contact |
MAX CHARTRAND |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 10/30/1986 |
Decision Date | 01/09/1987 |
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
|
|
|