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 K061459
Device Name TRANQUIL TRI-BTE
Applicant
General Hearing Instruments, Inc.
P.O. Box 23748
New Orleans,  LA  70183
Applicant Contact ROGER P JUNEAU
Correspondent
General Hearing Instruments, Inc.
P.O. Box 23748
New Orleans,  LA  70183
Correspondent Contact ROGER P JUNEAU
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/26/2006
Decision Date 06/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-