Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K884997 |
Device Name |
ITE HEARING AID PARKER/TECHNITONE, MODEL PA |
Applicant |
HEARING ENHANCEMENT CENTER, INC. |
128 MERCHANTS ROW |
RUTLAND,
VT
05701
|
|
Applicant Contact |
ROBERT L PARKER |
Correspondent |
HEARING ENHANCEMENT CENTER, INC. |
128 MERCHANTS ROW |
RUTLAND,
VT
05701
|
|
Correspondent Contact |
ROBERT L PARKER |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/01/1988 |
Decision Date | 03/29/1989 |
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
|
|
|