Clearance Summary
UNSCENTED MENSTRUAL PADS-MAXI PADS received FDA 510(k) clearance under submission number K813251, sponsored by I.C.D. Industries, 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 1981-12-14.
- Submission: K813251
- Applicant / Sponsor: I.C.D. Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1981-12-14
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.