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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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i-scope 200 DONGJIN MEDICAL CO., LTD k062364 12/06/2006
perfusor space infusion syringe pump system B. BRAUN MEDICAL, INC. k062699 10/26/2006
sorbact wound dressing ABIGO MEDICAL AB k063059 04/19/2007
15.5 fr decathlon gold, funnel tips, coated hemodialysis catheter, dfc19sh24, dfc23sh28, dfc27sh32, dfc31sh36, dfc35sh40 SPIRE BIOMEDICAL INC k063431 01/29/2007
matryx interference screw, 239038t5,231025t5,231033t5,231038t5,231125t5,231133t5,231138t5 CONMED LINVATEC BIOMATERIALS k063588 03/02/2007
power extenders model# pec200, pes200,pes200s POWER MEDICAL INTERVENTIONS, INC. k063746 01/12/2007
p-stim system NEUROSCIENCE THERAPY CORP. k050123 03/30/2006
aequalis reversed shoulder prosthesis TORNIER k050316 03/16/2005
t-sling HERNIAMESH S.R.L. k050516 02/03/2006
altaire HITACHI MEDICAL SYSTEMS AMERICA, INC. k050602 04/07/2005

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