Durafiber AG
FDA 510(k) K103793 · Smith & Nephew, Inc.
510(k) numberK103793
Submission
- Device name
- Durafiber AG
- Applicant
- Smith & Nephew, Inc.
St Petersburg, FL, US - Received
- December 27, 2010
- Decision date
- May 2, 2011
- 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 Durafiber AG cleared by the FDA?
Durafiber AG (K103793) received a 510(k) decision of Substantially Equivalent on May 2, 2011, 126 days after the submission was received.
What is the product code of K103793?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.