Cidex Formula 7* Long-Life Activated Dialdehyde
FDA 510(k) K924334 · Johnson & Johnson Medical, Inc.
510(k) numberK924334
Submission
- Device name
- Cidex Formula 7* Long-Life Activated Dialdehyde
- Applicant
- Johnson & Johnson Medical, Inc.
Arlington, TX, US - Received
- August 27, 1992
- Decision date
- March 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Formula 7* Long-Life Activated Dialdehyde cleared by the FDA?
Cidex Formula 7* Long-Life Activated Dialdehyde (K924334) received a 510(k) decision of Substantially Equivalent on March 29, 1994, 579 days after the submission was received.
What is the product code of K924334?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.