Clearance Summary
HTL MALE CONDOM received FDA 510(k) clearance under submission number K980019, sponsored by Reddy Medtech Health Products , 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 1998-04-01.
- Submission: K980019
- Applicant / Sponsor: Reddy Medtech Health Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1998-04-01
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.