Clearance Summary
MODIFICATION'S TO TORAY'S B-2 SERIES received FDA 510(k) clearance under submission number K863297, sponsored by National Medical Care, Medical Products Div., 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 1986-09-25.
- Submission: K863297
- Applicant / Sponsor: National Medical Care, Medical Products Div., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1986-09-25
Classification & Regulation
This clearance is catalogued under FDA product code FJT and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.