510(k) Report

Devices descending from K864181

2 later devices reach Somatics Mouth Guard (Bite Block) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050188EpiguardEpisafe Medical Devices, Ltd.20051—
+2K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…Dupaco, Inc.20150—