510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name permanent pacemaker electrode 510(k) Number K863781 Device Name MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD Applicant INTERMEDICS, INC. p.o. box 617 freeport,  TX  77541 061 Contact ken bishop Regulation Number 870.3680 Classification Product Code DTB   Date Received 09/26/1986 Decision Date 11/03/1986 Decision substantially equivalent (SE) Classification Advisory Committee Cardiovascular Review Advisory Committee Cardiovascular Type Traditional Reviewed by Third Party No Expedited Review