• 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
510(k) Number K933095
Device Name 351-AGCO BEHIND-THE-EAR HEARING AID
Applicant
TELEX COMMUNICATIONS, INC.
9600 aldrich avenue south
minneapolis,  MN  55420
Applicant Contact harry teder
Correspondent
TELEX COMMUNICATIONS, INC.
9600 aldrich avenue south
minneapolis,  MN  55420
Correspondent Contact harry teder
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/24/1993
Decision Date 07/26/1993
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
-
-