510(k) Report

Devices descending from K011433

2 later devices reach Ballert Cranial Molding Helmet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030669Providence Molding HelmetNortheast Orthotics and Prothetics, Inc.20031—
+2K070694Ccro (Craniocephalic Custom Remolding Orthosis)Mike Miner20070—