Clearance Summary
CERVICAL COLLAR received FDA 510(k) clearance under submission number K823667, sponsored by Warm & Form, Orthopedic Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1982-12-30.
- Submission: K823667
- Applicant / Sponsor: Warm & Form, Orthopedic Materials
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3490
- Decision date: 1982-12-30
Classification & Regulation
This clearance is catalogued under FDA product code IQK and 21 CFR 890.3490, within the Physical Medicine review panel as a Class I device.