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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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drystar 5500 AGFA CORP. k023287 10/22/2002
microvision scleral buckling components MICROVISION, INC. k023481 01/08/2003
access ov monitor immunoenzymetric assay BECKMAN COULTER, INC. k023597 12/11/2002
spsmedical sporview bacterial spore strip SPS MEDICAL SUPPLY CORP. k023716 12/05/2002
k-assay c-reactive protein (3), k-assay crp multi-calibrator d, k-assay crp multi-calibrator e, k-assay crp multi-calibr KAMIYA BIOMEDICAL CO. k023828 02/04/2003
bd phoenix automated microbiology system BECTON, DICKINSON & CO. k023858 12/20/2002
cook nephrostomy dilation balloon catheter set COOK UROLOGICAL, INC. k024050 02/27/2003
one touch ultra and one touch induo blood glucose monitoring systems LIFESCAN, INC. k024194 02/07/2003
npac multi-use ear thermometer, models td 600,610,620,630,602,612,622,632, tn 600,610,620,630,602,612,622,632, ts 600,6 NORM PACIFIC AUTOMATION CORP. k030126 02/07/2003
amsure red rubber urethral catheter AMSINO INTERNATIONAL, INC. k030293 02/04/2004

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