Clearance Summary
CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) received FDA 510(k) clearance under submission number K872356, sponsored by Mayer Laboratories. 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 1988-04-06.
- Submission: K872356
- Applicant / Sponsor: Mayer Laboratories
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1988-04-06
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.