Device Classification Name |
masker, tinnitus
|
510(k) Number |
K982432 |
Device Name |
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- |
Applicant |
TINNITUS TREATMENT CENTERS, INC. |
8215 WESTCHESTER, SUITE 150 |
DALLAS,
TX
75225 -6109
|
|
Applicant Contact |
DAVID W HOLMES |
Correspondent |
TINNITUS TREATMENT CENTERS, INC. |
8215 WESTCHESTER, SUITE 150 |
DALLAS,
TX
75225 -6109
|
|
Correspondent Contact |
DAVID W HOLMES |
Regulation Number | 874.3400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/13/1998 |
Decision Date | 01/25/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|