Clearance Summary
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) received FDA 510(k) clearance under submission number K011740, sponsored by Meddev Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-07-02.
- Submission: K011740
- Applicant / Sponsor: Meddev Corp.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5700
- Decision date: 2001-07-02
Classification & Regulation
This clearance is catalogued under FDA product code MML and 21 CFR 886.5700, within the Ophthalmic review panel as a Class II device.