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 Hearing Aid, Air-Conduction, Prescription
510(k) Number K954236
Device Name FACEPLATE (HEARING AID KIT)
Applicant
TRUETONE HEARING SYSTEMS, INC.
829 15TH ST.
MOLINE,  IL  61265
Applicant Contact CHARLES GILMORE
Correspondent
TRUETONE HEARING SYSTEMS, INC.
829 15TH ST.
MOLINE,  IL  61265
Correspondent Contact CHARLES GILMORE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/11/1995
Decision Date 12/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-