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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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triage b-type natriuretic peptide (bnp) test BIOSITE INCORPORATED den000010 11/20/2000
dulbecco's modified eagle medium (dmem) LIFE TECHNOLOGIES, INC. den000008 02/16/2001
quanta lite asca (s. cerevisiae) igg elisa INOVA DIAGNOSTICS, INC. den000007 08/16/2000
eros-clitoral therapy device (ctd) UROMETRICS, INC. den000006 04/28/2000
quickair choke reliever, model 59-001a MAET INDUSTRIES, INC. den000004 02/29/2000
urosurge percutaneous sans (stoller afferent nerve stimulator) device UROSURGE, INC. den000002 02/09/2000
ohmeda inovent delivery system OHMEDA MEDICAL den000001 01/11/2000
surflo winged infusion set TERUMO EUROPE N.V. k070362 05/07/2007
nuface, model nu-4003 Carol Cole Company k072260 11/27/2007
endowave infusion system EKOS CORP. k072507 10/04/2007

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