Clearance Summary
LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 received FDA 510(k) clearance under submission number K851291, sponsored by Manexim Multicorp, Ltd.. 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 1985-05-22.
- Submission: K851291
- Applicant / Sponsor: Manexim Multicorp, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1985-05-22
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.