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 K905784
Device Name CUSTOM ITE HEARING AID
Applicant
HEARING AID CO.
1188 BISHOP ST.
SUITE 2402
HONOLULU,  HI  96813
Applicant Contact RANDY WOHLERS
Correspondent
HEARING AID CO.
1188 BISHOP ST.
SUITE 2402
HONOLULU,  HI  96813
Correspondent Contact RANDY WOHLERS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/18/1990
Decision Date 03/18/1991
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
-
-