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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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servo-i ventilator system model 64 87 800 e4073, heliox option, model 6675585 MAQUET CRITICAL CARE AB k073179 06/09/2008
neurometrix advance NEUROMETRIX, INC. k070109 04/25/2008
n95 surgical respirator, type ap0018 and ap0028 SHUENN BAO SHING CORPORATION k072067 01/08/2008
passeo 18 BIOTRONIK, INC. k072765 12/12/2007
sterrad 100nx sterilizer ADVANCED STERILIZATION PRODUCTS k071385 11/29/2007
nuface, model nu-4003 Carol Cole Company k072260 11/27/2007
integradweb pacs system GE HEALTHCARE k072986 11/20/2007
raphael color asv ventilator HAMILTON MEDICAL AG k071194 10/18/2007
traverse oct spinal fixation system MEDTRONIC SOFAMOR DANEK, INC. k062447 10/15/2007
endowave infusion system EKOS CORP. k072507 10/04/2007

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