Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K960410 |
Device Name |
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR |
Applicant |
PERFECT EAR |
P.O. BOX 958405 |
LAKE MARY,
FL
32795
|
|
Applicant Contact |
DONALD E K CAMPBELL |
Correspondent |
PERFECT EAR |
P.O. BOX 958405 |
LAKE MARY,
FL
32795
|
|
Correspondent Contact |
DONALD E K CAMPBELL |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/29/1996 |
Decision Date | 04/04/1996 |
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
|
|
|