Clearance Summary
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 received FDA 510(k) clearance under submission number K993668, sponsored by Laerdal Medical A/S. 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 1999-12-20.
- Submission: K993668
- Applicant / Sponsor: Laerdal Medical A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1999-12-20
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.