• 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 K964669
Device Name MIRACLE-EAR OR AUDIOTONE
Applicant
MIRACLE-EAR, INC.
4101 DAHLBERG DR.
GOLDEN VALLEY,  MN  55422
Applicant Contact MELANIE RASKA
Correspondent
MIRACLE-EAR, INC.
4101 DAHLBERG DR.
GOLDEN VALLEY,  MN  55422
Correspondent Contact MELANIE RASKA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/21/1996
Decision Date 12/26/1996
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
-
-