Clearance Summary
PROTEX, TAHITI CONDOM received FDA 510(k) clearance under submission number K860680, sponsored by U. C. Import & Co.. 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 1986-09-26.
- Submission: K860680
- Applicant / Sponsor: U. C. Import & Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1986-09-26
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.