Algidex Ag Silver Alginate Wound Dressing
FDA 510(k) K173072 · Deroyal Industries, Inc.
510(k) numberK173072
Submission
- Device name
- Algidex Ag Silver Alginate Wound Dressing
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- September 29, 2017
- Decision date
- April 4, 2018
- 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 Algidex Ag Silver Alginate Wound Dressing cleared by the FDA?
Algidex Ag Silver Alginate Wound Dressing (K173072) received a 510(k) decision of Substantially Equivalent on April 4, 2018, 187 days after the submission was received.
What is the product code of K173072?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.