Clearance Summary
BEDDING, DISPOSABLE HOSPITAL received FDA 510(k) clearance under submission number K781796, 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 1978-12-07.
- Submission: K781796
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1978-12-07
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.