Clearance Summary
COOL CAST(R) received FDA 510(k) clearance under submission number K903946, sponsored by Hawthorne Products, 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 1990-12-31.
- Submission: K903946
- Applicant / Sponsor: Hawthorne Products, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5940
- Decision date: 1990-12-31
Classification & Regulation
This clearance is catalogued under FDA product code LGF and 21 CFR 888.5940, within the Orthopedic review panel as a Class I device.