Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K941834 |
Device Name |
AUDITORY CASSETTE |
Applicant |
LTMLT, INC. |
1030 NORTH CROOKS RD. |
SUITE P |
CLAWSON,
MI
48017
|
|
Applicant Contact |
MICHAEL J LAROUERE |
Correspondent |
LTMLT, INC. |
1030 NORTH CROOKS RD. |
SUITE P |
CLAWSON,
MI
48017
|
|
Correspondent Contact |
MICHAEL J LAROUERE |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 04/13/1994 |
Decision Date | 10/31/1994 |
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
|
|
|