Clearance Summary
SUCTION-OFF received FDA 510(k) clearance under submission number K863653, sponsored by B&B Medical Technologies, 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 1986-10-07.
- Submission: K863653
- Applicant / Sponsor: B&B Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-10-07
Classification & Regulation
This clearance is catalogued under FDA product code HXD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.