Clearance Summary
WHITE OCULAR PRESSURE RELIEF DEVICE received FDA 510(k) clearance under submission number K840204, 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 1985-02-15.
- Submission: K840204
- Applicant / Sponsor: Precision-Cosmet Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3920
- Decision date: 1985-02-15
Classification & Regulation
This clearance is catalogued under FDA product code KYF and 21 CFR 886.3920, within the Ophthalmic review panel as a Class II device.