Clearance Summary
PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL received FDA 510(k) clearance under submission number K934585, sponsored by Lafayette Pharmaceuticals, Inc.. 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 1993-11-03.
- Submission: K934585
- Applicant / Sponsor: Lafayette Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1993-11-03
Classification & Regulation
This clearance is catalogued under FDA product code FCD and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.