Clearance Summary
SUCTION TIP CLEANER CUP received FDA 510(k) clearance under submission number K952219, sponsored by Moore/Gobel. 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 1995-11-15.
- Submission: K952219
- Applicant / Sponsor: Moore/Gobel
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1995-11-15
Classification & Regulation
This clearance is catalogued under FDA product code GCX and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.