Clearance Summary
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 received FDA 510(k) clearance under submission number K011115, sponsored by Heinz Kurz GmbH Medizintechnik. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-05-02.
- Submission: K011115
- Applicant / Sponsor: Heinz Kurz GmbH Medizintechnik
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5700
- Decision date: 2001-05-02
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.