Clearance Summary
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 received FDA 510(k) clearance under submission number K850883, sponsored by Storz Instrument Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-03-20.
- Submission: K850883
- Applicant / Sponsor: Storz Instrument Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1985-03-20
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.