510(k) Report

Devices descending from K003630

2 later devices reach Danmar Products Michigan Cranial Helmet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc.20100—
+1K013452Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc.20030—