Clearance Summary
KNOW-RECIRC received FDA 510(k) clearance under submission number K953551, sponsored by H&H Control Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1996-06-21.
- Submission: K953551
- Applicant / Sponsor: H&H Control Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1996-06-21
Classification & Regulation
This clearance is catalogued under FDA product code MQS and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.