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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K142243
Device Name LessRay with Tracking
Applicant
SAFERAY SPINE, LLC
5102 Durham Chapel Hill Blvd. Suite 203
Durham,  NC  27707
Applicant Contact Michael Alrutz
Correspondent
BIOLOGICS CONSULTING GROUP, INC.
400 N. WASHINGTON STREET
SUITE 100
ALEXANDRIA,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   LLZ  
Date Received08/13/2014
Decision Date 11/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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