Clearance Summary
KRATZ NOVA SERT(TM) received FDA 510(k) clearance under submission number K883489, sponsored by Coopervision-Cilco. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-10-25.
- Submission: K883489
- Applicant / Sponsor: Coopervision-Cilco
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 1988-10-25
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.