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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 piezo-electric stimulator for relief of mosquito bite itch
De Novo Number DEN100024
Device Name ZAP-IT!
5401 s. cottonwood ct.
greenwood village,  CO  80121
Contact kevin walls
Regulation Number882.5894
Classification Product Code
Date Received09/09/2010
Decision Date 11/07/2014
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE