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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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eg-3870utk PENTAX MEDICAL COMPANY k090197 05/19/2009
ehc400 desktop patient station; ehc600 care provider station CYBERCARE TECHNOLOGIES, INC. k002984 12/18/2000
electronic blood pressure monitor SHENZHEN URION TECHNOLOGY CO., LTD. k141683 04/03/2015
elecys hgh calset, elecsys hgh calcheck 5 Roche Diagnostics k103221 12/23/2010
elipar freelight ESPE DENTAL AG k011154 05/16/2001
elittech clinical systems alp ifcc sl ELITECHGROUP k113269 12/29/2011
emerge external fixation system EMERGE MEDICAL, INC. k140675 06/10/2014
empi action patch iontophoresis system EMPI k030395 04/08/2003
emv3 self monitoring blood glucose system, emv3 pro self monitoring blood glucose system EPS BIO TECHNOLOGY CORP. k111728 09/16/2011
encore acclaim sterile powder-free latex surgical gloves, tested for use with chemothera ANSELL HEALTHCARE PRODUCTS, LLC k103714 07/07/2011

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