Clearance Summary
AIR MAX EXTERNAL NASAL DILATOR STRIP received FDA 510(k) clearance under submission number K962400, sponsored by American White Cross, Inc.. 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 1996-09-09.
- Submission: K962400
- Applicant / Sponsor: American White Cross, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3900
- Decision date: 1996-09-09
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.