Clearance Summary
NASOPORE EAR, MODELS ND04, ND05 received FDA 510(k) clearance under submission number K062540, sponsored by Polyganics B.V.,. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2006-10-18.
- Submission: K062540
- Applicant / Sponsor: Polyganics B.V.,
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 2006-10-18
Classification & Regulation
This clearance is catalogued under FDA product code KCN and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.