Clearance Summary
CALSSIQUE OR MYSTIQUE received FDA 510(k) clearance under submission number K932978, sponsored by Dekumed, Kunststofftechnik Degler GmbH. 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 1993-12-22.
- Submission: K932978
- Applicant / Sponsor: Dekumed, Kunststofftechnik Degler GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3800
- Decision date: 1993-12-22
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.