Clearance Summary
VED VALU- VACUUM ERECTION DEVICE received FDA 510(k) clearance under submission number K980948, sponsored by Mission Pharmacal Comp. 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 1998-06-25.
- Submission: K980948
- Applicant / Sponsor: Mission Pharmacal Comp
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1998-06-25
Classification & Regulation
This clearance is catalogued under FDA product code LKY and 21 CFR 876.5020, within the Gastroenterology, Urology review panel as a Class II device.