Clearance Summary
PREFILLED WATER FOR IRRIGATION USP received FDA 510(k) clearance under submission number K880316, sponsored by Automatic Liquid Packaging, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1988-02-29.
- Submission: K880316
- Applicant / Sponsor: Automatic Liquid Packaging, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1988-02-29
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.