Clearance Summary
CILCO VILLASENOR PACHYMETER received FDA 510(k) clearance under submission number K882805, sponsored by Coopervision-Cilco. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1988-08-12.
- Submission: K882805
- Applicant / Sponsor: Coopervision-Cilco
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1988-08-12
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.