510(k) Report

Devices descending from K003567

2 later devices reach Serenocem, Model BC 010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140644ProcemOtotronix, LLC20140—
+1K080032Envoycem, Model 1640Envoy Medical Corporation20081—