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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 K123226
Device Name LESSRAY
Applicant
SAFERAY SPINE, LLC
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Applicant Contact Calley Herzog
Correspondent
SAFERAY SPINE, LLC
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received10/15/2012
Decision Date 12/05/2012
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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