Clearance Summary
HUMAN II LENS received FDA 510(k) clearance under submission number K781927, sponsored by Spectra-Shield, 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 1978-12-20.
- Submission: K781927
- Applicant / Sponsor: Spectra-Shield, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1978-12-20
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.