Clearance Summary
PHARMASEAL EYE PREP TRAY received FDA 510(k) clearance under submission number K850119, sponsored by American Pharmaseal Div. Ahsc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-05-09.
- Submission: K850119
- Applicant / Sponsor: American Pharmaseal Div. Ahsc
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1985-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HNR and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.