510(k) Report

Devices descending from K974653

2 later devices reach Silicone Elastomer Sheeting through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033796Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSHeinz Kurz GmbH Medizintechnik20041—
+2K260266Tympendi™ (810)Grace Medical, Inc.20260—