Clearance Summary
DISPOSABLE STERILE SYRINGE FILTERS received FDA 510(k) clearance under submission number K875122, 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 1988-01-12.
- Submission: K875122
- Applicant / Sponsor: Corning Medical & Scientific
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1988-01-12
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.