Clearance Summary
AREOLA/NIPPLE DRESSING received FDA 510(k) clearance under submission number K882558, sponsored by Cooper Surgical/Aesthete. 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 1989-05-24.
- Submission: K882558
- Applicant / Sponsor: Cooper Surgical/Aesthete
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1989-05-24
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.