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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 K173314
Device Name LessRay System
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Manthan J. Damani
Correspondent
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Manthan J. Damani
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   LLZ  
Date Received10/19/2017
Decision Date 11/16/2017
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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