Clearance Summary
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM received FDA 510(k) clearance under submission number K100767, sponsored by Church & Dwight Co., 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 2011-04-05.
- Submission: K100767
- Applicant / Sponsor: Church & Dwight Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2011-04-05
Classification & Regulation
This clearance is catalogued under FDA product code MOL and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.