Clearance Summary
VACUUM SUCTION FILTER received FDA 510(k) clearance under submission number K812139, sponsored by K & G Healthcare Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1981-08-20.
- Submission: K812139
- Applicant / Sponsor: K & G Healthcare Ind., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1981-08-20
Classification & Regulation
This clearance is catalogued under FDA product code KDQ and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.