Clearance Summary
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL received FDA 510(k) clearance under submission number K963512, sponsored by Benz Research and Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-07-31.
- Submission: K963512
- Applicant / Sponsor: Benz Research and Development Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5916
- Decision date: 1997-07-31
Classification & Regulation
This clearance is catalogued under FDA product code HQD and 21 CFR 886.5916, within the Ophthalmic review panel as a Class II device.