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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K233151
Device Name PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
Applicant
Medline Industries, LP
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Dinah Rincones
Correspondent
Medline Industries, LP
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Dinah Rincones
Classification Product Code
FRO  
Date Received09/27/2023
Decision Date 03/26/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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