510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name activator, ultraviolet, for polymerization 510(k) Number K024374 Device Name RMO PLASMA CURING LIGHT Applicant LOKKI LASERS MEDICAUX 344 annabelle point rd. centerville,  MA  02632 240 Contact hillard w welch Regulation Number 872.6070 Classification Product Code EBZ   Date Received 12/31/2002 Decision Date 03/10/2003 Decision substantially equivalent (SE) Classification Advisory Committee Dental Review Advisory Committee Dental Statement/Summary/Purged Status Statement only statement statement Type Traditional Reviewed by Third Party No Expedited Review No