Clearance Summary
HYPODERMIC NEEDLES, SINGLE LUMEN received FDA 510(k) clearance under submission number K911397, sponsored by Popper & Sons, 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 1991-05-20.
- Submission: K911397
- Applicant / Sponsor: Popper & Sons, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1991-05-20
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.