Clearance Summary
O&P CRANICAL MOLDING HELMET received FDA 510(k) clearance under submission number K021221, 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 2002-07-01.
- Submission: K021221
- Applicant / Sponsor: Orthotic & Prosthetic Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2002-07-01
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.