Clearance Summary
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA received FDA 510(k) clearance under submission number K022807, sponsored by Creative Technologies, Inc.. 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 2003-01-29.
- Submission: K022807
- Applicant / Sponsor: Creative Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2003-01-29
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.