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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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acr 2500 cardiotomy reservoir filter Electromedics, Inc. k842391 05/21/1985
acmi bipolar rectoscope, model eiwe-br Acmi-Circon Corporation k021166 05/09/2002
acme guidewires for percutaneous insertion of cath Acme-Monaco Corp. k883763 11/18/1988
accuwarm emg heat lamp Rjl Associates, LLC k001800 09/12/2000
accelerator reciprocating cannula Byron Medical k001803 08/04/2000
abx pentra enzymatic creatinine cp, abx pentra multical, abx pentra n control, abx pentra p control, and abx pentra urin HORIBA ABX SAS k110137 08/10/2011
abl90 flex analyzer Radiometer Medical Aps k131988 09/17/2013
abbott plum a+3 multichannel infusion pump, model 12348 Abbott Laboratories k021350 05/14/2002
abbott lifecare 500 infuser Abbott Laboratories k844768 01/25/1985
a-gent trigllycerides gpo Abbott Laboratories k874187 01/21/1988

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