Clearance Summary
MOLDED CRANIAL HELMET received FDA 510(k) clearance under submission number K012920, sponsored by Fairview Orthopedic Laboratory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-11-28.
- Submission: K012920
- Applicant / Sponsor: Fairview Orthopedic Laboratory
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2001-11-28
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.