Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K864823 |
Device Name |
BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 |
Applicant |
BERNAFON, INC. |
1125 GLOBE AVE. |
P.O. BOX 1160 |
MOUNTAINSIDE,
NJ
07092
|
|
Applicant Contact |
TED MIDSIEWICZ |
Correspondent |
BERNAFON, INC. |
1125 GLOBE AVE. |
P.O. BOX 1160 |
MOUNTAINSIDE,
NJ
07092
|
|
Correspondent Contact |
TED MIDSIEWICZ |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/09/1986 |
Decision Date | 01/06/1987 |
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
|
|
|