Clearance Summary
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED received FDA 510(k) clearance under submission number K000039, sponsored by Indus Medicare , 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 2000-03-21.
- Submission: K000039
- Applicant / Sponsor: Indus Medicare , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2000-03-21
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.