Clearance Summary
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET received FDA 510(k) clearance under submission number K053283, sponsored by Pajunk GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2006-01-12.
- Submission: K053283
- Applicant / Sponsor: Pajunk GmbH
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 2006-01-12
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.