Clearance Summary
DEVILBISS MODEL 6300D received FDA 510(k) clearance under submission number K896090, sponsored by Devilbiss Health Care, 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 1989-11-30.
- Submission: K896090
- Applicant / Sponsor: Devilbiss Health Care, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1989-11-30
Classification & Regulation
This clearance is catalogued under FDA product code EPN and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.