Clearance Summary
CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY received FDA 510(k) clearance under submission number K902464, sponsored by Chartermed, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1990-08-30.
- Submission: K902464
- Applicant / Sponsor: Chartermed, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 1990-08-30
Classification & Regulation
This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.