Clearance Summary
AT EASE ADULT DIAPER received FDA 510(k) clearance under submission number K880455, sponsored by Hospital Specialty Co.. 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 1988-04-14.
- Submission: K880455
- Applicant / Sponsor: Hospital Specialty Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5920
- Decision date: 1988-04-14
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.