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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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510(K)
Number
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Decision
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at home drug testt, model 9150 t PHAMATECH k010655 04/05/2001
athos COSMOS MEDICAL TECHNOLOGY k001704 08/31/2000
audio technologies s:r.1 AUDIO TECHNOLOGIES S.R.L. k001142 06/23/2000
augustine medical bair huuger, model 750 total temperature management system-(model 750 warming unit, bair hugger blank AUGUSTINE MEDICAL, INC. k001149 09/06/2000
automatic blood pressure monitor with intellisense, model hem-757 OMRON HEALTHCARE, INC. k001670 06/30/2000
autostat ii anti-myeloperoxidase (mpo) elisa COGENT DIAGNOTICS LTD. k002215 09/28/2000
avita tso/ts1 infrared ear thermometer AVITA CORPORATION k002182 12/29/2000
baby dopplex 4000 (bd4000) HUNTLEIGH DIAGNOSTICS LTD. k001677 08/14/2000
barcomed 2mp2 BARCO NV k000015 02/04/2000
barcomed 5mp1h BARCO NV k000014 03/14/2000

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