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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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chlorinated, polymer-coated powder-free latex examination glove with protein labeling claim KOSSAN LATEX INDUSTRIES (M) SDN. BHD. k062965 12/22/2006
lifepak 20 defibrillator/ monitor MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. k063119 12/22/2006
enterococcus faecalis pna fish ADVANDX, INC. k063127 12/22/2006
powder free sterile nitrile surgical gloves (blue) HARTALEGA SDN BHD k062950 12/21/2006
film digitzer, model 2908 mammo pro ARRAY CORP. k063424 12/21/2006
dpilog, model dpc-512 LIFE OUTCOMES, INC. k062811 12/20/2006
xcel 255 slit lamp REICHERT INC. k063750 12/20/2006
ruike, model 3431 SHANGHAI RUIKE SPORTS GOODS CO., LTD. k062645 12/19/2006
nobelperfect conical connection NOBEL BIOCARE AB k062936 12/19/2006
needleless sling SPECIALITIES REMEEX INTERNATIONAL, S.L. k063136 12/19/2006

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