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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 K043088
Device Name MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Applicant Contact TINA DREILING
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Correspondent Contact TINA DREILING
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/08/2004
Decision Date 01/05/2005
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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