Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K974152 |
Device Name |
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) |
Applicant |
BERNAFON-MAICO, INC. |
9675 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
RAY ENROTH |
Correspondent |
BERNAFON-MAICO, INC. |
9675 WEST 76TH ST. |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
RAY ENROTH |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 11/04/1997 |
Decision Date | 12/15/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|