Clearance Summary
LARGE/EXTRA LAGRE CONDOM received FDA 510(k) clearance under submission number K113061, sponsored by Karex Industries Sdn. Bhd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-12-07.
- Submission: K113061
- Applicant / Sponsor: Karex Industries Sdn. Bhd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2011-12-07
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.