510(k) Report

Devices descending from K950763

3 later devices reach Lowe Klearway through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113516Therasom-CastFamily Dental Services, P.C.20132—
+2K170053Meridian PMThe Center For Craniofacial & Dental Sleep Medicine20170—
+2K150941Somnowell Mandibular Advancement Appliance (MAA)Somnowell, Ltd.20150—