Clearance Summary
FRACTURE CAST BRACE KIT, PLASTIC received FDA 510(k) clearance under submission number K770898, sponsored by Chase Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1977-07-21.
- Submission: K770898
- Applicant / Sponsor: Chase Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5890
- Decision date: 1977-07-21
Classification & Regulation
This clearance is catalogued under FDA product code HSP and 21 CFR 888.5890, within the Orthopedic review panel as a Class I device.