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FDA 510(k) Application Details - K201961
Device Classification Name
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510(K) Number
K201961
Device Name
IlluminOss Photodynamic Bone Stabilization System
Applicant
IlluminOss Medical, Inc.
993 Waterman Avenue
East Providence, RI 02914 US
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Contact
Robert Rabiner
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Regulation Number
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Classification Product Code
QAD
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Date Received
07/14/2020
Decision Date
08/13/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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