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 System, X-Ray, Mammographic
510(k) Number K992037
Device Name MAMEX
Applicant
Del Medical Imaging Corp.
11550 W. King St.
Franklin Park,  IL  60131
Applicant Contact JEFFREY N MOELLER
Correspondent
Del Medical Imaging Corp.
11550 W. King St.
Franklin Park,  IL  60131
Correspondent Contact JEFFREY N MOELLER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received06/16/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-