Clearance Summary
ENVIVE MINIFORMS received FDA 510(k) clearance under submission number K003843, sponsored by Procter & Gamble 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 2001-02-08.
- Submission: K003843
- Applicant / Sponsor: Procter & Gamble Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 2001-02-08
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.