Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K862036 |
Device Name |
MODEL HP HEARING AID |
Applicant |
FINE-TUNE |
916 DELTONA BLVD, STE #102 |
DELTONA,
FL
32725
|
|
Applicant Contact |
C. A CHARI |
Correspondent |
FINE-TUNE |
916 DELTONA BLVD, STE #102 |
DELTONA,
FL
32725
|
|
Correspondent Contact |
C. A CHARI |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/29/1986 |
Decision Date | 06/23/1986 |
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
|
|
|