Clearance Summary
ALGINATE FIBER received FDA 510(k) clearance under submission number K914779, sponsored by Adri/Technam. 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 1991-12-04.
- Submission: K914779
- Applicant / Sponsor: Adri/Technam
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4018
- Decision date: 1991-12-04
Classification & Regulation
This clearance is catalogued under FDA product code NAC and 21 CFR 878.4018, within the General, Plastic Surgery review panel as a Class I device.