Clearance Summary
FOCUS TOUCH CONCEPTION SYSTEM received FDA 510(k) clearance under submission number K112200, sponsored by Intimate Bridge 2 Conception, 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 2012-09-06.
- Submission: K112200
- Applicant / Sponsor: Intimate Bridge 2 Conception, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 2012-09-06
Classification & Regulation
This clearance is catalogued under FDA product code OBB and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.