Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K944039 |
Device Name |
BEHIND THE EAR HEARING AID |
Applicant |
AUDICRAFT HEARING INSTRUMENTS |
P.O. BOX 877 |
CASSELBERRY,
FL
32718 -0877
|
|
Applicant Contact |
FRANK J ROBILOTTA |
Correspondent |
AUDICRAFT HEARING INSTRUMENTS |
P.O. BOX 877 |
CASSELBERRY,
FL
32718 -0877
|
|
Correspondent Contact |
FRANK J ROBILOTTA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/18/1994 |
Decision Date | 12/23/1994 |
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
|
|
|