Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K900789 |
Device Name |
HEARING AID (ALL-IN-THE-EAR) |
Applicant |
SOLAR AID CORP. |
239 EAST WATER ST. |
SYRACUSE,
NY
13202
|
|
Applicant Contact |
BOB RAIMO |
Correspondent |
SOLAR AID CORP. |
239 EAST WATER ST. |
SYRACUSE,
NY
13202
|
|
Correspondent Contact |
BOB RAIMO |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 02/20/1990 |
Decision Date | 04/04/1990 |
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
|
|
|