Clearance Summary
COMPAT ENTERAL FEED PUMP 199235 & 199240 received FDA 510(k) clearance under submission number K891575, sponsored by Sandoz Nutrition. 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 1989-09-12.
- Submission: K891575
- Applicant / Sponsor: Sandoz Nutrition
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1989-09-12
Classification & Regulation
This clearance is catalogued under FDA product code LZH and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.