Clearance Summary
AMBU UNIVERSAL SUCTION PUMP received FDA 510(k) clearance under submission number K792592, sponsored by Narco Air-Shields. 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 1980-01-11.
- Submission: K792592
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1980-01-11
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.