Clearance Summary
COTTON UNDER CAST PADDING received FDA 510(k) clearance under submission number K800195, sponsored by Winn Hirsch & Assoc.. 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 1980-02-11.
- Submission: K800195
- Applicant / Sponsor: Winn Hirsch & Assoc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1980-02-11
Classification & Regulation
This clearance is catalogued under FDA product code ITG and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.