Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name masker, tinnitus
510(k) Number K040330
Device Name QUIESCENCE
Applicant
SPECTRAL VISUALIZATION & DEVELOPMENT, INC.
921 COLLEGE HILL RD.
FREDERICTON, NEW BRUNSWICK,  CA E3B 6Z9
Applicant Contact DENNIS WOO
Correspondent
SPECTRAL VISUALIZATION & DEVELOPMENT, INC.
921 COLLEGE HILL RD.
FREDERICTON, NEW BRUNSWICK,  CA E3B 6Z9
Correspondent Contact DENNIS WOO
Regulation Number874.3400
Classification Product Code
KLW  
Date Received02/11/2004
Decision Date 04/12/2004
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
-
-