Clearance Summary
PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT received FDA 510(k) clearance under submission number K921095, sponsored by Pacer Tool & Plastics, 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 1992-04-29.
- Submission: K921095
- Applicant / Sponsor: Pacer Tool & Plastics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1992-04-29
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.