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 Grid, Radiographic
510(k) Number K883527
Device Name GRID/RADIOGRAPHIC
Applicant
Umi, Inc.
2190 S. Mason Rd.,
Suite 304
St. Louis,  MO  63131
Applicant Contact MARIA BONASTIA
Correspondent
Umi, Inc.
2190 S. Mason Rd.,
Suite 304
St. Louis,  MO  63131
Correspondent Contact MARIA BONASTIA
Regulation Number892.1910
Classification Product Code
IXJ  
Date Received08/18/1988
Decision Date 09/02/1988
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
-
-