FDA 510(k) Application Details - K140812

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K140812
Device Name Light, Surgical, Ceiling Mounted
Applicant MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO, CA 91340 US
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Contact ROBERT HESS
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 04/01/2014
Decision Date 08/07/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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