Clearance Summary
SAFECON CONDOMS - RIBBED received FDA 510(k) clearance under submission number K884454, sponsored by Quality Synthetics Intl, 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 1989-04-25.
- Submission: K884454
- Applicant / Sponsor: Quality Synthetics Intl, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1989-04-25
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.