Clearance Summary
STERILIZATION PROCESS/MATERNITY PAD received FDA 510(k) clearance under submission number K792627, 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 1980-01-28.
- Submission: K792627
- Applicant / Sponsor: Procter & Gamble Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 1980-01-28
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.