510(k) Report

Devices descending from K091011

1 later device reach Pureform Eptfe Facial Implants (Nasal, Chin, Maler) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.20230—