Clearance Summary
UNSCENTED MENSTRUAL LINER received FDA 510(k) clearance under submission number K953488, sponsored by Paragon Trade Brands, 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 1995-08-09.
- Submission: K953488
- Applicant / Sponsor: Paragon Trade Brands, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1995-08-09
Classification & Regulation
This clearance is catalogued under FDA product code HHD and 21 CFR 884.5435, within the Obstetrics/Gynecology review panel as a Class I device.