Clearance Summary
FEMTEX 100% COTTON TAMPONS received FDA 510(k) clearance under submission number K971228, sponsored by Regu-Tech Assoc., 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 1997-04-09.
- Submission: K971228
- Applicant / Sponsor: Regu-Tech Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 1997-04-09
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.