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 Motor, Drill, Pneumatic
510(k) Number K020069
Device Name MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
Applicant
Medtronic Midas Rex
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact GREG CANNEDY
Correspondent
Medtronic Midas Rex
4620 N Beach St.
Fort Worth,  TX  76137
Correspondent Contact GREG CANNEDY
Regulation Number882.4370
Classification Product Code
HBB  
Date Received01/09/2002
Decision Date 03/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-