510(k) Report

Devices descending from K113516

2 later devices reach Therasom-Cast through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+1K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—