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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 light based treatment for cold sores herpes simplex virus-1
De Novo Number DEN090012
510(K) Number K083767
Device Name VIRULITE COLD SORE MACHINE
Requester
virulite, llc
5405 alton pkwy., 5a
suite 530
irvine,  CA  92604
Contact beky pine
Regulation Number878.4860
Classification Product Code
OKJ  
Date Received06/30/2009
Decision Date 10/18/2012
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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