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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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510(K)
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Decision
Date
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cleanse s+ ultrasonic scaler DMETEC CO., LTD. k060171 03/29/2006
rema shaver blades REMA MEDIZINTECHNIK GMBH. k060172 05/31/2006
acon 30 second reliable digital thermometer, acon digital thermometer probe covers ACON LABORATORIES, INC. k060173 03/17/2006
spectrum five lumen central venous catheter set, model c-uqlm10.0-abrm COOK, INC. k060174 02/17/2006
isight imaging catheter, model 38986 BOSTON SCIENTIFIC CORP. k060175 03/24/2006
el-acl screen; el-acl igm, igg, iga THERATEST LABORATORIES, INC. k060176 02/07/2006
kls martin rigid fixation - sterile KLS MARTIN L.P. k060177 04/18/2006
vix win pro GENDEX DENTAL SYSTEMS k060178 03/10/2006
bio-ray sdx digital x-ray system SIGMA BIOMEDICS, INC. k060179 02/08/2006
bioset xc REGENERATION TECHNOLOGIES, INC. k060180 09/06/2006

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