Clearance Summary
MEDISHIELD CERVICAL COLLAR received FDA 510(k) clearance under submission number K770910, sponsored by Fraser Sweatman, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1977-05-25.
- Submission: K770910
- Applicant / Sponsor: Fraser Sweatman, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5890
- Decision date: 1977-05-25
Classification & Regulation
This clearance is catalogued under FDA product code HSS and 21 CFR 888.5890, within the Orthopedic review panel as a Class I device.