Clearance Summary
HESUNG'S BLOOD DONOR SETS received FDA 510(k) clearance under submission number K841561, sponsored by Amkor Trading Co.. 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 1984-08-30.
- Submission: K841561
- Applicant / Sponsor: Amkor Trading Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1984-08-30
Classification & Regulation
This clearance is catalogued under FDA product code BRZ and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.