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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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ems kermit (EMS SA) ELECTRO MEDICAL SYSTEMS k992504 01/27/2000
3m clinpro sealant 3M COMPANY k992326 10/08/1999
3m tr system 3M COMPANY k992489 01/11/2000
a-miniature centrifugal blood pump system, model cpb 2000 A-MED SYSTEMS, INC. k992592 05/04/2000
piccolo metlyte 7 reagent disc ABAXIS, INC. k992140 08/26/1999
abbott imx glycated hemoglobin ii ABBOTT LABORATORIES k992085 05/25/2000
modification of: cell-dyn 1200 system ABBOTT LABORATORIES k992444 09/24/1999
abx pentra 60 hematology analyzer ABX DIAGNOSTICS k992511 10/15/1999
ultegra system analyzer, ultegra system rpfa-trap test cartidges, ultegra system rpfa-trap level one qc, ultegra system ACCUMETRICS, INC. k992531 12/20/1999
guardian low pressure alarm accessory, model 34076 ACCUTRON, INC. k992421 10/27/1999

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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