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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 scalp cooling system
De Novo Number DEN150010
Device Name Dignitana AB DigniCap System
Requester
dignitana ab
traktorgranden 3
lund,  SE se-226 60
Contact jan richardsson
Regulation Number878.4360
Classification Product Code
PMC  
Date Received03/06/2015
Decision Date 12/08/2015
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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