Clearance Summary
IODOSORB GEL received FDA 510(k) clearance under submission number K905069, sponsored by Perstorp AB C/O Robert Joel Slomoff. 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 1991-01-31.
- Submission: K905069
- Applicant / Sponsor: Perstorp AB C/O Robert Joel Slomoff
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4018
- Decision date: 1991-01-31
Classification & Regulation
This clearance is catalogued under FDA product code KOZ and 21 CFR 878.4018, within the General, Plastic Surgery review panel as a Class I device.