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 Unit, X-Ray, Extraoral With Timer
510(k) Number K931001
Device Name ORALIX DC
Applicant
GENDEX CORP.
901 WEST OAKTON ST.
DES PLAINES,  IL  60018
Applicant Contact ROBERT E UEBERFLUSS
Correspondent
GENDEX CORP.
901 WEST OAKTON ST.
DES PLAINES,  IL  60018
Correspondent Contact ROBERT E UEBERFLUSS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/26/1993
Decision Date 09/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-