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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 K020338
Device Name STEALTHSTATION WITH FLUOROMERGE SOFTWARE
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 Received02/01/2002
Decision Date 02/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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