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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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sensititre haemophilus/streptococcus pneumoniae (hp) mic plate TREK DIAGNOSTIC SYSTEMS, INC. k012921 11/02/2001
transonic syringe warmer, model syr-1000 TRANSONIC SYSTEMS, INC. k022963 12/04/2002
aequalis shoulder fracture system TORNIER k994392 03/10/2000
aequalis universal shoulder glenoid TORNIER k994393 06/22/2000
silk touch powdered latex examination glove with protein content labeling claim (200 micrograms or less) TOP QUALITY MFG., INC. k013821 03/05/2002
ud-1000 ultrasonic a/b scanner TOMEY CORP. USA k020151 04/10/2002
thermo trace ammonia standards set, models tr-609 THERMO DMA, INC. k012878 10/16/2001
flu oia a/b test kit THERMO BIOSTAR, INC. k023556 03/27/2003
nonlinear taper lag screw THEKEN SURGICAL k994382 03/10/2000
dogbone acfs THEKEN SURGICAL k994383 02/04/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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