Clearance Summary
MERCATOR HEALTHCARE MALE LATEX CONDOM received FDA 510(k) clearance under submission number K031369, sponsored by Mercator Healthcare , Ltd.. 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 2003-10-31.
- Submission: K031369
- Applicant / Sponsor: Mercator Healthcare , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2003-10-31
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.