Clearance Summary
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS received FDA 510(k) clearance under submission number K051446, sponsored by First Quality Hygienic, 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 2005-07-14.
- Submission: K051446
- Applicant / Sponsor: First Quality Hygienic, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 2005-07-14
Classification & Regulation
This clearance is catalogued under FDA product code HIL and 21 CFR 884.5460, within the Obstetrics/Gynecology review panel as a Class II device.