Clearance Summary
DISARP ORIGINAL received FDA 510(k) clearance under submission number K802248, sponsored by Unoplast A/S. 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 1980-09-26.
- Submission: K802248
- Applicant / Sponsor: Unoplast A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4495
- Decision date: 1980-09-26
Classification & Regulation
This clearance is catalogued under FDA product code GAO and 21 CFR 878.4495, within the General, Plastic Surgery review panel as a Class II device.