Clearance Summary
ACE/KYLE SELF TAPPING CANNULATED TITA received FDA 510(k) clearance under submission number K833866, sponsored by Buckman Co., 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 1983-12-27.
- Submission: K833866
- Applicant / Sponsor: Buckman Co., Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1983-12-27
Classification & Regulation
This clearance is catalogued under FDA product code JPW and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.