Clearance Summary
WHENEVER UNSCENTED REGULAR THIN MAXI-PADS received FDA 510(k) clearance under submission number K861355, sponsored by Marcal Paper Mills, 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 1986-04-23.
- Submission: K861355
- Applicant / Sponsor: Marcal Paper Mills, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1986-04-23
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.