Clearance Summary
CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON received FDA 510(k) clearance under submission number K844671, sponsored by Corning Medical & Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1985-02-25.
- Submission: K844671
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1985-02-25
Classification & Regulation
This clearance is catalogued under FDA product code KET and 21 CFR 864.3010, within the Pathology review panel as a Class I device.