Clearance Summary
ulrich Transfer Set received FDA 510(k) clearance under submission number K161723, sponsored by Ulrich GmbH & Co. KG. 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 2016-12-21.
- Submission: K161723
- Applicant / Sponsor: Ulrich GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2016-12-21
Classification & Regulation
This clearance is catalogued under FDA product code PQH and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.