Clearance Summary
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. received FDA 510(k) clearance under submission number K902305, sponsored by Armkel, LLC. 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 1991-03-29.
- Submission: K902305
- Applicant / Sponsor: Armkel, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1991-03-29
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.