Clearance Summary
LERMAN & SON CRANIAL ORTHOSIS HELMET received FDA 510(k) clearance under submission number K012830, sponsored by Lerman & Son. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-11-20.
- Submission: K012830
- Applicant / Sponsor: Lerman & Son
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2001-11-20
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.