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 K964510
Device Name UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
Applicant
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061 -5010
Applicant Contact JERRY G JOHNSON
Correspondent
Unitron Industries, Inc.
3555 Walnut St.
P.O. Box 5010
Port Huron,  MI  48061 -5010
Correspondent Contact JERRY G JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/08/1996
Decision Date 11/27/1996
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
Predetermined Change
Control Plan Authorized		 No
-
-