Clearance Summary
SNO STRIPS STERILE TEARFLOW TEST STRIP received FDA 510(k) clearance under submission number K832181, sponsored by Smith & Nephew, 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 1983-08-12.
- Submission: K832181
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1800
- Decision date: 1983-08-12
Classification & Regulation
This clearance is catalogued under FDA product code KYD and 21 CFR 886.1800, within the Ophthalmic review panel as a Class I device.