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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K081512
Device Name STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
Applicant
Medtronic Navigation, Inc.
3025 Perry St.
Denver,  CO  80212
Applicant Contact KEVIN MORNINGSTAR
Correspondent
Medtronic Navigation, Inc.
3025 Perry St.
Denver,  CO  80212
Correspondent Contact KEVIN MORNINGSTAR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/30/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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