Clearance Summary
PETRUS IOL GUIDE received FDA 510(k) clearance under submission number K840104, sponsored by Precision-Cosmet Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-04-24.
- Submission: K840104
- Applicant / Sponsor: Precision-Cosmet Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 1984-04-24
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.