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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K092308
Device Name POLESTAR, MODEL N-30
Applicant
Medtronic Navigation Israel, Ltd.
Kochav Yokneam
Bldg. P.O. Box 548
Yokneam Elit,  IL 20692
Applicant Contact YAIR PENIAS
Correspondent
Medtronic Navigation Israel, Ltd.
Kochav Yokneam
Bldg. P.O. Box 548
Yokneam Elit,  IL 20692
Correspondent Contact YAIR PENIAS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/30/2009
Decision Date 03/16/2010
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
Recalls CDRH Recalls
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