Medline Burn and Wound Dressing
FDA 510(k) K173911 · Medline Industries, Inc.
510(k) numberK173911
Submission
- Device name
- Medline Burn and Wound Dressing
- Applicant
- Medline Industries, Inc.
Northfiled, IL, US - Received
- December 22, 2017
- Decision date
- July 19, 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 Medline Burn and Wound Dressing cleared by the FDA?
Medline Burn and Wound Dressing (K173911) received a 510(k) decision of Substantially Equivalent on July 19, 2018, 209 days after the submission was received.
What is the product code of K173911?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.