Clearance Summary
INFECTION CONTROL TOWEL received FDA 510(k) clearance under submission number K822484, sponsored by American Threshold Industries, 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 1982-09-30.
- Submission: K822484
- Applicant / Sponsor: American Threshold Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1982-09-30
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.