Clearance Summary
PROVIDENCE MOLDING HELMET received FDA 510(k) clearance under submission number K030669, sponsored by Northeast Orthotics and Prothetics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-07-18.
- Submission: K030669
- Applicant / Sponsor: Northeast Orthotics and Prothetics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2003-07-18
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.