Clearance Summary
COMFORM ABSORBANT INCONTINENCE PADS received FDA 510(k) clearance under submission number K781375, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1978-09-20.
- Submission: K781375
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1978-09-20
Classification & Regulation
This clearance is catalogued under FDA product code EYQ and 21 CFR 876.5920, within the Gastroenterology, Urology review panel as a Class I device.