Clearance Summary
UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI received FDA 510(k) clearance under submission number K932984, sponsored by Sime Health, 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 1994-07-07.
- Submission: K932984
- Applicant / Sponsor: Sime Health, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1994-07-07
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.