The following data is part of a premarket notification filed by Medtronic Midas Rex with the FDA for Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System Or Legend System.
Device ID | K020069 |
510k Number | K020069 |
Device Name: | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM |
Classification | Motor, Drill, Pneumatic |
Applicant | MEDTRONIC MIDAS REX 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
Contact | Greg Cannedy |
Correspondent | Greg Cannedy MEDTRONIC MIDAS REX 4620 NORTH BEACH ST. Fort Worth, TX 76137 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-09 |
Decision Date | 2002-03-18 |
Summary: | summary |