Clearance Summary
PRIVATE LABE/ DEODORANT MAXIPAD received FDA 510(k) clearance under submission number K830630, sponsored by Int'L Consumer Disposables. 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 1983-04-18.
- Submission: K830630
- Applicant / Sponsor: Int'L Consumer Disposables
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5425
- Decision date: 1983-04-18
Classification & Regulation
This clearance is catalogued under FDA product code HHL and 21 CFR 884.5425, within the Obstetrics/Gynecology review panel as a Class II device.