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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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echoview/ shimasonic diagnostic ultrasound system, model sdu-2200pro SHIMADZU MEDICAL SYSTEMS k061637 07/25/2006
integra radionics xknife rt 4 INTEGRA RADIONICS, INC. k061893 07/25/2006
medrelief st series, models rt-50, st-100, st 150, st-200, st-300 HEALTHONICS, INC. k060669 10/13/2006
xeron pacs XERON HEALTHCARE CORP. k062757 11/07/2006
digital mxr-d flowmeter PORTER INSTRUMENT CO., INC. k062155 11/09/2006
fmp coated spiked acetabular cup; hemispherical acetabular cup; flared rim acetabular cup; metal/metal acetabular insert ENCORE MEDICAL, L.P. k063257 11/22/2006
ltd polyaxial fixation system US SPINE k062785 12/26/2006
philips xd-s direct radiography workstation/package PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. k063781 01/05/2007
disposable hypodermic emg needle electrode technomed europe version and private labeled TECHNOMED EUROPE k062437 02/16/2007
asc-12 piezoelectric scaler ASEPTICO, INC. k070866 04/11/2007

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