Clearance Summary
WEBRIL CAST PADDING received FDA 510(k) clearance under submission number K820140, sponsored by Stan-Pak Ent.. 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 1982-02-12.
- Submission: K820140
- Applicant / Sponsor: Stan-Pak Ent.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1982-02-12
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.