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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 antimicrobial keyboard
De Novo Number DEN100013
510(K) Number K092996
Device Name VIOGUARD SELF-SANITIZING KEYBOARD, MODEL UVKB50
Requester
vioguard
1725 220th st. se
suite 201
bothell,  WA  98021
Contact craig ranta
Regulation Number880.6600
Classification Product Code
OSZ  
Date Received11/05/2010
Decision Date 12/20/2011
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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