Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K933963 |
Device Name |
PAL (PERSONAL AMPLIFIER FOR LISTENING) |
Applicant |
HEARING CARE PRODUCTS, INC. |
591 REDWOOD HWY., #2125 |
MILL VALLEY,
CA
94941
|
|
Applicant Contact |
TOM J COWLEY |
Correspondent |
HEARING CARE PRODUCTS, INC. |
591 REDWOOD HWY., #2125 |
MILL VALLEY,
CA
94941
|
|
Correspondent Contact |
TOM J COWLEY |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 08/16/1993 |
Decision Date | 12/15/1993 |
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
|
|
|