Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K021202 |
Device Name |
ULTRAQUIET |
Applicant |
SOUND TECHNIQUE SYSTEM, LLC |
555 THIRTTEENTH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
SOUND TECHNIQUE SYSTEM, LLC |
555 THIRTTEENTH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 04/16/2002 |
Decision Date | 07/13/2002 |
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
|
|
|