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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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dmlc iv-ergo 3D LINE USA, INC. k001163 10/23/2000
handpiece sheath-model #a910 AARON MEDICAL, INC. k011929 09/18/2001
etest esbl ct/ctl strip; etest esbl tz/tzl strip AB BIODISK k001547 08/07/2000
abbott gemstar i.v. infusion pump - 7 therapy configuration, 6 therapy configuration, 1 therapy configuration ABBOTT LABORATORIES k000821 03/24/2000
sof-tact diabetes management system; sof-tact glucose test strip; precision control solutions ABBOTT LABORATORIES k001993 11/13/2000
abbott plum a+infusion pump, model 11971 ABBOTT LABORATORIES k011442 06/05/2001
access cardiosystems manual defibrillator ACCESS CARDIOSYSTEMS, INC. k011461 05/28/2002
acist angiographic injection system, model r-2000 ACIST MEDICAL SYSTEMS k000013 03/28/2000
quik-check home pregnancy test ACON LABORATORIES, INC. k012215 08/07/2001
quik-check ovulation predictor ACON LABORATORIES, INC. k012252 08/24/2001

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