Clearance Summary
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 received FDA 510(k) clearance under submission number K000127, sponsored by Heinz Kurz GmbH Medizintechnik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-04-12.
- Submission: K000127
- Applicant / Sponsor: Heinz Kurz GmbH Medizintechnik
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5700
- Decision date: 2000-04-12
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.