Clearance Summary
AMOENA AFFINITY MODEL #802 received FDA 510(k) clearance under submission number K915382, sponsored by Coloplast Corp.. 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 1992-01-14.
- Submission: K915382
- Applicant / Sponsor: Coloplast Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3800
- Decision date: 1992-01-14
Classification & Regulation
This clearance is catalogued under FDA product code KCZ and 21 CFR 878.3800, within the General, Plastic Surgery review panel as a Class I device.