Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K853172 |
Device Name |
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI |
Applicant |
INT'L HEARING AIDS, INC. |
P.O. BOX 255 |
HOPKINS,
MN
55343
|
|
Applicant Contact |
PATRICIA J BING |
Correspondent |
INT'L HEARING AIDS, INC. |
P.O. BOX 255 |
HOPKINS,
MN
55343
|
|
Correspondent Contact |
PATRICIA J BING |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/30/1985 |
Decision Date | 10/17/1985 |
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
|
|
|