Clearance Summary
CLAY-PARK LABS, INC. - LUBRICATING JELLY received FDA 510(k) clearance under submission number K012203, sponsored by Clay-Park Labs, 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 2001-08-27.
- Submission: K012203
- Applicant / Sponsor: Clay-Park Labs, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2001-08-27
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.