Clearance Summary
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO received FDA 510(k) clearance under submission number K926477, sponsored by Core Dynamics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-11-12.
- Submission: K926477
- Applicant / Sponsor: Core Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1993-11-12
Classification & Regulation
This clearance is catalogued under FDA product code GBW and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.