Cidex Activated Dialdehyde Solution
FDA 510(k) K060618 · Johnson & Johnson Co.
510(k) numberK060618
Submission
- Device name
- Cidex Activated Dialdehyde Solution
- Applicant
- Johnson & Johnson Co.
Irvin, CA, US - Received
- March 8, 2006
- Decision date
- April 12, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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Questions and answers
When was Cidex Activated Dialdehyde Solution cleared by the FDA?
Cidex Activated Dialdehyde Solution (K060618) received a 510(k) decision of Substantially Equivalent on April 12, 2006, 35 days after the submission was received.
What is the product code of K060618?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.