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 Processor, Radiographic-Film, Automatic, Dental
510(k) Number K945682
Device Name PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
Applicant
Gendex Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact JAMES E KETTNER
Correspondent
Gendex Corp.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact JAMES E KETTNER
Regulation Number892.1900
Classification Product Code
EGY  
Date Received11/21/1994
Decision Date 02/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-