Clearance Summary
HANGER CRANIAL BAND received FDA 510(k) clearance under submission number K072566, sponsored by Hanger Prosthetics & Orthotics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2008-01-09.
- Submission: K072566
- Applicant / Sponsor: Hanger Prosthetics & Orthotics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2008-01-09
Classification & Regulation
This clearance is catalogued under FDA product code OAN and 21 CFR 882.5970, within the Neurology review panel as a Class II device.