K140353 Trade / The 3dMD Systems / 3dMD Inc. / Orthomerica Products Inc. / 3M / Cranial Technologies Inc. / Manufacturer Site Orthomerica Products Inc. / /
Event
FDA Phase / /
Facility
North Orange Blossom Trail / New Hamrpshire Avenue Document Control Center / /
IndustryTerm
proposed shape capture device / predicate shape capture device / announcements concerning your device / Internet address htn /
Organization
MIS Director Division of Neurological / Division of Postmarket Surveillance / Food and Drug Administration / New Hamrpshire Avenue Document Control Center / Neurological and Physical Medicine Devices Office / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / /
Person
Carlos L.Pena / David Hooper / Carlos L. Pefia / / /
STARband* and STARlight Cranial Orthosis 510(k) Summary JUN1062014