FDA 510(k) Application Details - K133554

Device Classification Name Light, Surgical, Accessories

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510(K) Number K133554
Device Name Light, Surgical, Accessories
Applicant MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
370 WABASHA STREET N
ST. PAUL, MN 55102 US
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Contact ANDY ROLLER
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Regulation Number 878.4580

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Classification Product Code FTA
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Date Received 11/19/2013
Decision Date 04/08/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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