Clearance Summary
MODEL 2300 GENERAL PURPOSE SUCTION PUMP received FDA 510(k) clearance under submission number K941527, sponsored by Product & Educational Services. 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 1994-05-18.
- Submission: K941527
- Applicant / Sponsor: Product & Educational Services
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1994-05-18
Classification & Regulation
This clearance is catalogued under FDA product code JCX and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.