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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image-intensified fluoroscopic x-ray system, mobile
510(k) Number K092564
Device Name O-ARM IMAGING SYSTEM
Applicant
MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 FOSTER STREET
LITTLETON,  MA  01460
Applicant Contact SETH KUZDZAL
Correspondent
MEDTRONIC NAVIGATION, INC. (LITTLETON)
300 FOSTER STREET
LITTLETON,  MA  01460
Correspondent Contact SETH KUZDZAL
Regulation Number892.1650
Classification Product Code
OXO  
Date Received08/20/2009
Decision Date 06/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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