Clearance Summary
DOUBLE SPRINGERS NONOXNOL 9 CONDOM received FDA 510(k) clearance under submission number K012969, sponsored by Medtech Products , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-06-12.
- Submission: K012969
- Applicant / Sponsor: Medtech Products , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5310
- Decision date: 2002-06-12
Classification & Regulation
This clearance is catalogued under FDA product code LTZ and 21 CFR 884.5310, within the Obstetrics/Gynecology review panel as a Class II device.