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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 K101168
Device Name LEGEND POWER ADAPTER MODEL: 6475000
Applicant
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact THERESA LEISTER
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact THERESA LEISTER
Regulation Number882.4370
Classification Product Code
HBB  
Subsequent Product Code
GET  
Date Received04/26/2010
Decision Date 08/24/2010
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
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