• 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 K924450
Device Name MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL
Applicant
MEDIPHONIX, INC.
HWY 129 S.
CLEVELAND,  GA  30528
Applicant Contact PHILLIP RECHISTER
Correspondent
MEDIPHONIX, INC.
HWY 129 S.
CLEVELAND,  GA  30528
Correspondent Contact PHILLIP RECHISTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/31/1992
Decision Date 10/05/1992
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
-
-