Clearance Summary
Youjia Unscented Tampon with Plastic Applicators received FDA 510(k) clearance under submission number K192557, sponsored by Qingdao Youjia Hygiene Technology Co., Ltd.. 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 2020-02-13.
- Submission: K192557
- Applicant / Sponsor: Qingdao Youjia Hygiene Technology Co., Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2020-02-13
Classification & Regulation
This clearance is catalogued under FDA product code HEB and 21 CFR 884.5470, within the Obstetrics/Gynecology review panel as a Class II device.