Clearance Summary
OLYMPUS SUCTION PUMP, MODEL KV-5 received FDA 510(k) clearance under submission number K011725, sponsored by Keymed (Medical & Industrial Equipment), Ltd.. 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 2001-08-31.
- Submission: K011725
- Applicant / Sponsor: Keymed (Medical & Industrial Equipment), Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2001-08-31
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.