Clearance Summary
DELTA-ROL received FDA 510(k) clearance under submission number K790340, sponsored by Johnson & Johnson Professionals, 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 1979-04-12.
- Submission: K790340
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1979-04-12
Classification & Regulation
This clearance is catalogued under FDA product code GCO and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.