Clearance Summary
TS 564/PF received FDA 510(k) clearance under submission number K950247, sponsored by Bressler, Amery & Ross. 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 1995-11-17.
- Submission: K950247
- Applicant / Sponsor: Bressler, Amery & Ross
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1995-11-17
Classification & Regulation
This clearance is catalogued under FDA product code FJK and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.