Clearance Summary
HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS received FDA 510(k) clearance under submission number K943654, sponsored by Mdt Biologic 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 1995-08-02.
- Submission: K943654
- Applicant / Sponsor: Mdt Biologic Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6860
- Decision date: 1995-08-02
Classification & Regulation
This clearance is catalogued under FDA product code MLR and 21 CFR 880.6860, within the General Hospital review panel as a Class II device.