Clearance Summary
CVS PERSONAL LUBRICANT received FDA 510(k) clearance under submission number K983216, sponsored by San-Mar Laboratories, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-05-17.
- Submission: K983216
- Applicant / Sponsor: San-Mar Laboratories, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1999-05-17
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.