PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
FDA 510(k) K233151 · Medline Industries, LP
510(k) numberK233151
Submission
- Device name
- PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
- Applicant
- Medline Industries, LP
Northfiled, IL, US - Received
- September 27, 2023
- Decision date
- March 26, 2024
- 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 PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) cleared by the FDA?
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) (K233151) received a 510(k) decision of Substantially Equivalent on March 26, 2024, 181 days after the submission was received.
What is the product code of K233151?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.