Clearance Summary
MODIFIED L.J.'S SEX HELPER received FDA 510(k) clearance under submission number K882531, sponsored by L.J. Fant & 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 1988-12-08.
- Submission: K882531
- Applicant / Sponsor: L.J. Fant & Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1988-12-08
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.