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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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spyglass irrigation system MEDICAL SCIENTIFIC, INC. k063700 02/08/2007
ssafe plus disposable safety syringe, 3 cc and 5 cc DOLOMITE BIOTECH SDN BHD k070117 08/06/2007
zoll e series with see-thru cpr ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS k070455 04/26/2007
conmed linvatec xo button CONMED LINVATEC k070780 08/21/2007
kd-595 fully automatic electronic blood pressure monitor KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., k070828 08/15/2007
modification to pinnacle constrained acetabular liners DEPUY ORTHOPAEDICS, INC. k071117 05/18/2007
polaris be rods BIOMET SPINE k071377 08/06/2007
capiox fx05 hollow fiber oxygenator with integrated arterial filter TERUMO CORP. k071572 07/23/2007
hero vascular access device GRAFTCATH INC. k071778 01/30/2008
serenity pro psf system INOLASE 2002, LTD. k071943 08/10/2007

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