Clearance Summary
HEMO-SANITAS SYRINGE received FDA 510(k) clearance under submission number K884921, sponsored by Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger. 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 1989-02-09.
- Submission: K884921
- Applicant / Sponsor: Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1989-02-09
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.