Clearance Summary
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS received FDA 510(k) clearance under submission number K870394, sponsored by Clinical Connections, 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 1987-03-03.
- Submission: K870394
- Applicant / Sponsor: Clinical Connections, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1987-03-03
Classification & Regulation
This clearance is catalogued under FDA product code FIB and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.