Clearance Summary
STERILE GENERAL HOSPITAL SUPPLIES received FDA 510(k) clearance under submission number K851390, sponsored by Biological & Environmental Control Laboratories. 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 1985-05-29.
- Submission: K851390
- Applicant / Sponsor: Biological & Environmental Control Laboratories
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1985-05-29
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.