510(k) Report

Devices descending from K933367

2 later devices reach Gore-Tex Facial Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091011Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl")20091—
+2K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.20230—