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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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dar-8000f SHIMADZU MEDICAL SYSTEMS k052500 10/17/2005
aneroid sphygmanometer with stethoscope, model hs-50a SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. k051021 06/20/2005
non sterile synthetic powder free (yellow) vinyl patient examination gloves SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. k041041 06/08/2004
serim peracetic acid chemical indicator SERIM RESEARCH CORP. k052388 12/01/2005
qms zonisamide reagents, calibrators and controls SERADYN INC. k051211 11/18/2005
crp diagnostic assay SENTINEL CH. SRL k050836 08/08/2005
sentinel cholinesterase liquid SENTINEL CH. SRL k051444 06/20/2005
sentinel pancreatic amylase SENTINEL CH. SRL k051447 01/26/2006
sentinel clin chem cal SENTINEL CH. SRL k051452 10/25/2005
sentinel ceruloplasmin SENTINEL CH. SRL k051456 10/21/2005

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