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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 K150216
Device Name Synergy Cranial
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Applicant Contact KAYE E. WAITE
Correspondent
MEDTRONIC NAVIGATIONS, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Correspondent Contact KAYE E. WAITE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/30/2015
Decision Date 06/11/2015
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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