Clearance Summary
CIDEX ACTIVATED DIALDEHYDE SOLUTION received FDA 510(k) clearance under submission number K060618, sponsored by Johnson & Johnson Co.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-04-12.
- Submission: K060618
- Applicant / Sponsor: Johnson & Johnson Co.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6885
- Decision date: 2006-04-12
Classification & Regulation
This clearance is catalogued under FDA product code MED and 21 CFR 880.6885, within the General Hospital review panel as a Class II device.