Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K881480 |
Device Name |
FIRST AMERICAN, RADIONIC, JKR, MODEL AC |
Applicant |
JKR LABORATORIES, INC. |
10701 WEST KELLOGG |
P.O. BOX 12201 |
WICHITA,
KS
67209
|
|
Applicant Contact |
JERRY BLUE |
Correspondent |
JKR LABORATORIES, INC. |
10701 WEST KELLOGG |
P.O. BOX 12201 |
WICHITA,
KS
67209
|
|
Correspondent Contact |
JERRY BLUE |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 04/05/1988 |
Decision Date | 08/11/1988 |
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
|
|
|