Clearance Summary
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT received FDA 510(k) clearance under submission number K895502, sponsored by Microbio-Medics, 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 1989-12-08.
- Submission: K895502
- Applicant / Sponsor: Microbio-Medics, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5800
- Decision date: 1989-12-08
Classification & Regulation
This clearance is catalogued under FDA product code EPP and 21 CFR 874.5800, within the Ear, Nose, Throat review panel as a Class I device.