Clearance Summary
O&P BIVALVE CRANIAL MOLDING HELMET received FDA 510(k) clearance under submission number K063395, sponsored by Orthotic & Prosthetic Lab, 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 2006-12-22.
- Submission: K063395
- Applicant / Sponsor: Orthotic & Prosthetic Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2006-12-22
Classification & Regulation
This clearance is catalogued under FDA product code MVA and 21 CFR 882.5970, within the Neurology review panel as a Class II device.