Clearance Summary
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE received FDA 510(k) clearance under submission number K901078, sponsored by L H M Ent., 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 1990-05-18.
- Submission: K901078
- Applicant / Sponsor: L H M Ent., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1990-05-18
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.