Clearance Summary
CONDOM received FDA 510(k) clearance under submission number K960710, sponsored by Polar Latex , Ltd.. 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 1996-10-10.
- Submission: K960710
- Applicant / Sponsor: Polar Latex , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1996-10-10
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.