ULTRAQUIET


Device Classification Name

masker, tinnitus

510(k) Number K021202
Device Name ULTRAQUIET
Original Applicant
SOUND TECHNIQUE SYSTEM, LLC
555 thirtteenth st. n.w.
washington, 
DC 
20004

Original Contact howard m holstein
Regulation Number 874.3400
Classification Product Code
KLW  
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