Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K964898 |
Device Name |
IN THE EAR HEARING AID |
Applicant |
KEYTONE HEARING LABORATORY |
11701 I-30, SUITE 100 |
LITTLE ROCK,
AR
72209
|
|
Applicant Contact |
KRISTI KEY |
Correspondent |
KEYTONE HEARING LABORATORY |
11701 I-30, SUITE 100 |
LITTLE ROCK,
AR
72209
|
|
Correspondent Contact |
KRISTI KEY |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/06/1996 |
Decision Date | 04/21/1997 |
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
|
|
|