Clearance Summary
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET received FDA 510(k) clearance under submission number K023572, sponsored by Rehabilitation Institute,Loma Linda University Med. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-01-13.
- Submission: K023572
- Applicant / Sponsor: Rehabilitation Institute,Loma Linda University Med
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2003-01-13
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.