Clearance Summary
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR received FDA 510(k) clearance under submission number K963558, sponsored by Contemporary Products, 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 1996-12-04.
- Submission: K963558
- Applicant / Sponsor: Contemporary Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1996-12-04
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.