Clearance Summary
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST received FDA 510(k) clearance under submission number K902446, sponsored by Mallinckrodt Group, Inc.. 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 1990-08-10.
- Submission: K902446
- Applicant / Sponsor: Mallinckrodt Group, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6190
- Decision date: 1990-08-10
Classification & Regulation
This clearance is catalogued under FDA product code FMW and 21 CFR 880.6190, within the General Hospital review panel as a Class I device.