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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K012937
Device Name KNEE MODULE FOR THE STEALTHSTATION SYSTEM
Applicant
Medtronic Surgical Navigation Technologies
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact VICTORIA G RENDON
Correspondent
Medtronic Surgical Navigation Technologies
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact VICTORIA G RENDON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/31/2001
Decision Date 01/25/2002
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
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