Clearance Summary
MODIFIED EVA-MIX AND DI-MIX BAGS received FDA 510(k) clearance under submission number K880506, sponsored by Gil-Med Industries C/O Kegan & Kegan, Ltd.. 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 1988-05-20.
- Submission: K880506
- Applicant / Sponsor: Gil-Med Industries C/O Kegan & Kegan, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 1988-05-20
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.