Clearance Summary
NU-CATH EMERGENCY KIT received FDA 510(k) clearance under submission number K850398, sponsored by Intl. Medical Devices , 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 1985-03-27.
- Submission: K850398
- Applicant / Sponsor: Intl. Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1985-03-27
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.