Clearance Summary
TAMPON, RELY MODIFIED received FDA 510(k) clearance under submission number K780243, sponsored by Procter & Gamble Mfg. Co.. 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 1978-03-02.
- Submission: K780243
- Applicant / Sponsor: Procter & Gamble Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 1978-03-02
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.