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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 K190224
Device Name Medline Burn and Wound Dressing (OTC)
Applicant
Medline Industries, Inc.
Three Lake Dr.
Northfiled,  IL  60093
Applicant Contact Claire Pigman
Correspondent
Medline Industries, Inc.
Three Lake Dr.
Northfiled,  IL  60093
Correspondent Contact Claire Pigman
Classification Product Code
FRO  
Date Received02/05/2019
Decision Date 03/08/2019
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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