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U.S. Department of Health and Human Services

510(K) Premarket Notification

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accuclot drvvt confirm, catalog no. a62119 SIGMA DIAGNOSTICS, INC. k000528 04/07/2000
accuclot drvvt screen, catalog no. a6094 SIGMA DIAGNOSTICS, INC. k000527 04/07/2000
achieva ventilator y-ach+e, achieva ps ventilator y-achps+e, achieva pso2 ventilator y-achps02+e NELLCOR PURITAN BENNETT, INC. k002686 10/18/2000
acmi invisio icn, models icn-0564 and icn-0565 ACMI CORPORATION k042225 09/10/2004
acrotherm AQUARIUS MEDICAL CORP. k003368 01/19/2001
action af-1 wheelchair INVACARE CORP. k000174 02/18/2000
additional assays for bayer advia ims system BAYER CORP. k000903 05/18/2000
aems v, ems-1000, model ts-140500 and aems vi, ems-1000 plus, model ts-140600 APEX MEDICAL CORP. k002339 08/24/2001
aeroneb portable nebulizer AEROGEN, INC. k003022 10/13/2000
aesculap bone wax AESCULAP, INC. k000021 03/24/2000

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