• 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 Equipment, Traction, Powered
510(k) Number K031227
Device Name LORDEX POWER TRACTION EQUIPMENT
Applicant
EVER PROSPEROUS INSTRUMENT INC
15915 KATY FREEWAY
SUITE 645
HOUSTON,  TX  77094
Applicant Contact JOHN BOREN
Correspondent
EVER PROSPEROUS INSTRUMENT INC
15915 KATY FREEWAY
SUITE 645
HOUSTON,  TX  77094
Correspondent Contact JOHN BOREN
Regulation Number890.5900
Classification Product Code
ITH  
Date Received04/18/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-