Clearance Summary
SOF-ROL CAST PADDING received FDA 510(k) clearance under submission number K820139, sponsored by Stan-Pak Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1982-02-05.
- Submission: K820139
- Applicant / Sponsor: Stan-Pak Ent.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1982-02-05
Classification & Regulation
This clearance is catalogued under FDA product code NAB and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.