Clearance Summary
UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) received FDA 510(k) clearance under submission number K760164, sponsored by Parke-Davis Co.. 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 1976-07-20.
- Submission: K760164
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1976-07-20
Classification & Regulation
This clearance is catalogued under FDA product code EYQ and 21 CFR 876.5920, within the Gastroenterology, Urology review panel as a Class I device.