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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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510(K)
Number
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Decision
Date
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inovo, inc. independence oxygen conserving regulator INOVO, INC. k051540 09/21/2005
endopath endocutter 60 endoscopic linear cutter ETHICON ENDO-SURGERY, INC. k051002 05/17/2005
mevis liveranalyser/liverviewer software MEVIS TECHNOLOGY GMBH & CO. KG k051528 07/20/2005
mdi gliadin g test MICRO DETECT, INC. k002359 10/19/2000
agfa cr50.0 AGFA CORP. k050810 04/21/2005
landlex model s400x CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER k050793 07/07/2005
inion anchron biodegradable anchor system, model anc-6000 INION OY k051362 08/04/2005
mondeal radius ho system, model ks-mr-2005 KAPP SURGICAL INSTRUMENT, INC. k050655 08/08/2005
l.e. demetron ii KERR CORPORATION (DANBURY) k051545 07/18/2005
fortitude vue vertebral body replacement device SPINAL CONCEPTS, INC. k051000 05/19/2005

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