Clearance Summary
EXTRA PROTECTION POLYURETHANE CONDOM received FDA 510(k) clearance under submission number K922688, sponsored by Apex Medical Technologies, 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 1995-05-04.
- Submission: K922688
- Applicant / Sponsor: Apex Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1995-05-04
Classification & Regulation
This clearance is catalogued under FDA product code MOL and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.