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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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sentinel cholinesterase liquid SENTINEL CH. SRL k051444 06/20/2005
milliken silver wound dressings MILLIKEN CHEMICAL k051445 08/22/2005
femtex and private label opal fresh scented plastic applicator tampons FIRST QUALITY HYGIENIC INC. k051446 07/14/2005
sentinel pancreatic amylase SENTINEL CH. SRL k051447 01/26/2006
modified contact-heat evoked potential stimulator (cheps) MEDOC LTD. ADVANCED MEDICAL SYSTEMS k051448 06/29/2005
ge vivid 7 with or without suffix GE MEDICAL SYSTEMS k051449 06/16/2005
extended measurements system INOVISE MEDICAL, INC. k051450 11/10/2005
sentinel clin chem cal SENTINEL CH. SRL k051452 10/25/2005
aleutian spacer system K2M, LLC k051454 07/27/2005
wieslab cap mpo-anca EURODIAGNOSTICA k051455 11/23/2005

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