Clearance Summary
I.V. PLASTIC BAG received FDA 510(k) clearance under submission number K811233, sponsored by Medi-Plast Intl., 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 1981-06-17.
- Submission: K811233
- Applicant / Sponsor: Medi-Plast Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 1981-06-17
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.