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 Holder, Head, Radiographic
510(k) Number K884847
Device Name MTD HEDREST
Applicant
Composites Horizons, Inc.
1471 Industrial Park St.
Covina,  CA  91722
Applicant Contact M. H ANDERSON
Correspondent
Composites Horizons, Inc.
1471 Industrial Park St.
Covina,  CA  91722
Correspondent Contact M. H ANDERSON
Regulation Number892.1920
Classification Product Code
IWY  
Date Received11/21/1988
Decision Date 01/09/1989
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
-
-