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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 NORTH BEACH ST.
fort worth,  TX  76137
Applicant Contact greg cannedy
Correspondent
MEDTRONIC MIDAS REX
4620 NORTH 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
Recalls CDRH Recalls
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