Clearance Summary
ILO MADE IN ITALY; GARBO HAND FINISHED ITALY received FDA 510(k) clearance under submission number K943296, sponsored by Ilo Industria Lombarda Ottica Srl. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-09-14.
- Submission: K943296
- Applicant / Sponsor: Ilo Industria Lombarda Ottica Srl
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1994-09-14
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.