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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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clinical oxygen dose recorder (codr), model 300-cr INSPIRED TECHNOLOGIES, INC. k082853 03/23/2009
clip partial prosthesis-titanium dresden, model 1002 250-257 HEINZ KURZ GMBH MEDIZINTECHNIK k013573 11/09/2001
co2 monitoring line, co2 monitoring line with filter FLEXICARE k133516 04/30/2014
cobas integra online dat ii methadone ii ROCHE DIAGNOSTICS CORP. k021512 07/16/2002
codman bactiseal barium striped catheters Codman & Shurtleff, Inc. k031123 05/14/2003
codman microcoil delivery system, deltamaxx microcoil delivery system, orbit galaxy g2 microcoil delivery system, enpower control cable, connector cable Codman & Shurtleff, Inc k142429 12/24/2014
columbus total knee system as AESCULAP IMPLANT SYSTEMS, INC. k071220 06/01/2007
combison 301 pw ultrasound system and transducers MEDISON CO., LTD. k002491 08/25/2000
comborehab SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. k150436 11/13/2015
complete brand multi-purpose solution ADVANCED MEDICAL OPTICS, INC. k030092 04/04/2003

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