Clearance Summary
CELLULOSE EYE STICK received FDA 510(k) clearance under submission number K761155, sponsored by Winn Hirsch & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1976-12-16.
- Submission: K761155
- Applicant / Sponsor: Winn Hirsch & Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1976-12-16
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.