Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K942189 |
Device Name |
CRYSTAL EAR |
Applicant |
CRYSTAL CARE INTL., INC. |
1919 VANDERVORT RD. |
LUTZ,
FL
33549
|
|
Applicant Contact |
MICHAEL NEHR |
Correspondent |
CRYSTAL CARE INTL., INC. |
1919 VANDERVORT RD. |
LUTZ,
FL
33549
|
|
Correspondent Contact |
MICHAEL NEHR |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/04/1994 |
Decision Date | 08/09/1994 |
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
|
|
|