Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K913502 |
Device Name |
PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT |
Applicant |
PHONAK, INC. |
850 E. DIEHL RD. |
P.O. BOX 3017 |
NAPERVILLE,
IL
60566
|
|
Applicant Contact |
BILL LESIECKI |
Correspondent |
PHONAK, INC. |
850 E. DIEHL RD. |
P.O. BOX 3017 |
NAPERVILLE,
IL
60566
|
|
Correspondent Contact |
BILL LESIECKI |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/07/1991 |
Decision Date | 09/06/1991 |
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
|
|
|