510(k) K060618

CIDEX ACTIVATED DIALDEHYDE SOLUTION by Johnson & Johnson Co. — Product Code MED

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