510(k) K060618
K060618 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Co. for the device "CIDEX ACTIVATED DIALDEHYDE SOLUTION". The FDA issued a decision of Substantially Equivalent on April 12, 2006. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Johnson & Johnson Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2006
- Date Received
- March 8, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type