Clearance Summary
K-Y BRAND SENSUAL MIST received FDA 510(k) clearance under submission number K053397, sponsored by Mcneil-Ppc, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2006-02-17.
- Submission: K053397
- Applicant / Sponsor: Mcneil-Ppc, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2006-02-17
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.