Clearance Summary
DEPEND UNDERPAD received FDA 510(k) clearance under submission number K870522, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-03-13.
- Submission: K870522
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1987-03-13
Classification & Regulation
This clearance is catalogued under FDA product code KME and 21 CFR 880.6060, within the General Hospital review panel as a Class I device.