510(k) Report

Devices descending from K090812

5 later devices reach Theraform Standard/Sheet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112580Collagen Wound DressingDalim Tissen Co., Ltd.20124—
+2K182725ApisSweetbio, Inc.20192—
+2K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+3K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+3K211972Omeza Collagen MatrixOmeza, LLC20210—