Allevyn AG Dressing
FDA 510(k) K063835 · Smith & Nephew, Inc.
510(k) numberK063835
Submission
- Device name
- Allevyn AG Dressing
- Applicant
- Smith & Nephew, Inc.
Largo, FL, US - Received
- December 26, 2006
- Decision date
- August 3, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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Questions and answers
When was Allevyn AG Dressing cleared by the FDA?
Allevyn AG Dressing (K063835) received a 510(k) decision of Substantially Equivalent on August 3, 2007, 220 days after the submission was received.
What is the product code of K063835?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.