Clearance Summary
K-Y BRAND WARMING JELLY PERSONAL LUBRICANT received FDA 510(k) clearance under submission number K040164, sponsored by Personal Products Company, Div. of Mcneil-Ppc, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2004-04-05.
- Submission: K040164
- Applicant / Sponsor: Personal Products Company, Div. of Mcneil-Ppc, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2004-04-05
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.