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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
510(k) Number K201961
Device Name IlluminOss Photodynamic Bone Stabilization System
Applicant
Illuminoss Medical, Inc.
993 Waterman Ave.
East Providence,  RI  02914
Applicant Contact Robert Rabiner
Correspondent
MCRA, LLC
993 Waterman Ave.
East Providence,  RI  02914
Correspondent Contact Robert Rabiner
Regulation Number888.3023
Classification Product Code
QAD  
Date Received07/14/2020
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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