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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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apl medical system BIOS S.R.L. k072344 12/03/2007
intuition, model 0170 ARCOMA AB k073632 01/10/2008
pointcare now system POINTCARE TECHNOLOGIES INC. k072869 01/14/2008
unicompartmental knee VALPO ORTHOPEDIC TECHNOLOGY, INC. k072704 02/19/2008
wallflex partially covered esophageal stent system BOSTON SCIENTIFIC CORP. k073266 02/27/2008
omni-vue system GENESIS DIGITAL IMAGING, INC. k073062 03/10/2008
pass spinal system MEDICREA TECHNOLOGIES k080099 04/09/2008
karl storz scb/conmed esu interface module, model 20091522 KARL STORZ ENDOSCOPY-AMERICA, INC. k080410 04/09/2008
oncentra gyn NUCLETRON CORPORATION k080929 04/16/2008
sm-extra wide (rbm) implant system DIO DEPARTMENT DSI, INC. k080128 05/14/2008

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