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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name semi-automated autologous skin graft harvesting and application device
De Novo Number DEN210049
Device Name Medline ART Skin Harvesting System
Requester
medline industries, inc
three lakes drive
northfield,  IL  60093
Contact stephanie augsburg
Regulation Number878.4795
Classification Product Code
QYK  
Date Received10/19/2021
Decision Date 03/27/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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