Clearance Summary
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS received FDA 510(k) clearance under submission number K893499, sponsored by Cmsi. 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 1989-11-16.
- Submission: K893499
- Applicant / Sponsor: Cmsi
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4140
- Decision date: 1989-11-16
Classification & Regulation
This clearance is catalogued under FDA product code EQJ and 21 CFR 874.4140, within the Ear, Nose, Throat review panel as a Class I device.