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 K897035
Device Name MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
Applicant
Miracle-Ear, Inc.
7731 Country Club Dr.
Golden Valley,  MN  55427
Applicant Contact KEVIN L KUTINA
Correspondent
Miracle-Ear, Inc.
7731 Country Club Dr.
Golden Valley,  MN  55427
Correspondent Contact KEVIN L KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/18/1989
Decision Date 05/23/1990
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
-
-