Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K950912 |
Device Name |
MEGA-SIL A-B |
Applicant |
MICROSONIC, INC. |
1421 MERCHANT ST. |
P.O. BOX 184 |
AMBRIDGE,
PA
15003
|
|
Applicant Contact |
MIKLOS MAJOR |
Correspondent |
MICROSONIC, INC. |
1421 MERCHANT ST. |
P.O. BOX 184 |
AMBRIDGE,
PA
15003
|
|
Correspondent Contact |
MIKLOS MAJOR |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 02/27/1995 |
Decision Date | 03/21/1995 |
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
|
|
|