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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 K132970
Device Name LESSRAY
Applicant
Saferay Spine, LLC
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Applicant Contact Calley Herzog
Correspondent
Saferay Spine, LLC
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received09/23/2013
Decision Date 11/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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