Clearance Summary
STERISEAL OPHTHALMIC CANNULA received FDA 510(k) clearance under submission number K943932, sponsored by Pharma-Plast, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-01-18.
- Submission: K943932
- Applicant / Sponsor: Pharma-Plast, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1995-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.