Clearance Summary
ANGEL LATEX PROPHYLACTICS (CONDOMS) received FDA 510(k) clearance under submission number K871948, sponsored by Angel Intl. Trading Co., 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 1987-10-20.
- Submission: K871948
- Applicant / Sponsor: Angel Intl. Trading Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1987-10-20
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.