Clearance Summary
SAN-MAR LABS LUBRICATING JELLY received FDA 510(k) clearance under submission number K041667, sponsored by San-Mar Laboratories, 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 2005-01-13.
- Submission: K041667
- Applicant / Sponsor: San-Mar Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2005-01-13
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.