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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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modification to ebi efix vision fixation system EBI, L.P. k011711 06/29/2001
glycosal ii hba 1c test PROVALIS DIAGNOSTICS LTD. k011933 11/02/2001
avita agil it 101 instant digital thermometer AVITA CORPORATION k012136 09/10/2001
human igg subclass liquid reagent kits, product code lk001.ta THE BINDING SITE, LTD. k012291 08/20/2001
pdx-2000 portable digital x-ray system TREX ENTERPRISES CORP. k012379 08/16/2001
reprocessed sealed electrophysiology diagnostic catheters STERILMED, INC. k012678 08/14/2002
modification to: csc14 blood cardioplegia system COBE CARDIOVASCULAR, INC. k012898 09/17/2001
sonopsy HAKKO MEDICAL CO., LTD. k013109 03/12/2002
modification to: pocketview ecg software MICROMEDICAL INDUSTRIES, LTD. k013311 01/03/2002
modification to:philips m3000a/m3046a compact portable patient monitor, models philips m3000a/m3046a PHILIPS MEDICAL SYSTEMS, INC. k013427 11/29/2001

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