Clearance Summary
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 received FDA 510(k) clearance under submission number K023039, sponsored by Tuta Healthcare Pty Limited. 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 2002-11-07.
- Submission: K023039
- Applicant / Sponsor: Tuta Healthcare Pty Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2002-11-07
Classification & Regulation
This clearance is catalogued under FDA product code BRZ and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.