Clearance Summary
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm received FDA 510(k) clearance under submission number K150518, sponsored by Dupaco, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-06-29.
- Submission: K150518
- Applicant / Sponsor: Dupaco, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5070
- Decision date: 2015-06-29
Classification & Regulation
This clearance is catalogued under FDA product code JXL and 21 CFR 882.5070, within the Neurology review panel as a Class II device.