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510(k) Summary Trinity ELE Device Updated: October 1st, 2013 CONTACT INFORMATION Rand Daoud, Compliance Specialist Carol Cole Company
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Document Date: 2013-11-14 08:33:08


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City

Vista / /

Company

Table K131251 Trinity ELE Device Carol Cole Company / Compliance Specialist Carol Cole Company / K 131251 Trade / DeviceK103472 NuFACE8 Trinity Carol Cole Company / The Carol Cole Company / /

Event

FDA Phase / /

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Modulated Square / Pulsed Biphasic Pulsed Biphasic Modulated Square / /

IndustryTerm

Internet address http /

OperatingSystem

Microsoft Vista / /

Organization

Division of Postmarket Surveillance / Center for Devices and Radiological Health / Neurological and Physical Medicine Devices Office / FDA / Device Evaluation Center for Devices and Radiological Health Indications for Use / Acting Director Division of Neurological / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /

Person

Enclosure Victor Krauthamer / Rand Daoud / Joyce M.Whang / /

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Product

Federal Food / /

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Maryland / California / /

Technology

radiation / /

URL

www.fda.nov / http /

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