Clearance Summary
NOZOVENT, NASAL DILATOR received FDA 510(k) clearance under submission number K904290, sponsored by Wpm Intl AB Intl Trade & Managemet Consulting. 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 1991-08-20.
- Submission: K904290
- Applicant / Sponsor: Wpm Intl AB Intl Trade & Managemet Consulting
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3900
- Decision date: 1991-08-20
Classification & Regulation
This clearance is catalogued under FDA product code LWF and 21 CFR 874.3900, within the Ear, Nose, Throat review panel as a Class I device.