Clearance Summary
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT received FDA 510(k) clearance under submission number K902804, sponsored by Okamoto USA, Inc.. 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 1990-08-13.
- Submission: K902804
- Applicant / Sponsor: Okamoto USA, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1990-08-13
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.