510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name shunt, central nervous system and components 510(k) Number K853215 Device Name ACCU-FLO PRESSURE VALVE Applicant CODMAN & SHURTLEFF, INC. 41 pacella park dr. randolph industrial park randolph,  MA  02368 179 Contact donald a lincoln Regulation Number 882.5550 Classification Product Code JXG   Date Received 08/01/1985 Decision Date 09/16/1985 Decision substantially equivalent (SE) Classification Advisory Committee Neurology Review Advisory Committee Neurology Type Traditional Reviewed by Third Party No Expedited Review