Clearance Summary
SUCTION TIP received FDA 510(k) clearance under submission number K893667, sponsored by Thomson & Shelton Instrumentation Co, 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 1989-08-21.
- Submission: K893667
- Applicant / Sponsor: Thomson & Shelton Instrumentation Co, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1989-08-21
Classification & Regulation
This clearance is catalogued under FDA product code JOL and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.