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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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ek/p. aeruginosa pna fish ADVANDX, INC. k081433 03/26/2009
enduro knee system AESCULAP IMPLANT SYSTEMS k101815 12/20/2010
oxygen tubing (crush resistant)/vinyl tp AIRLIFE, INC. k801190 05/23/1980
humidifier w/ or w/out adaptor AIRLIFE, INC. k811161 06/24/1981
stereotactic head and neck localizer, model 50-100 AKTINA MEDICAL PHYSICS CORP. k081935 10/07/2008
ligmaject ALAN J. KHEDARRI D.D.S., INC. k802483 11/12/1980
novakone spherical and toric lenses ALDEN OPTICAL LABS., INC. k102557 04/26/2011
esteem sterile polyisoprene surgical gloves ALLEGIANCE HEALTHCARE CORP. k011721 08/14/2001
blood pressure monitoring devices ALLIED HEALTHCARE PRODUCTS, INC. k822614 09/21/1982
allwin embryo transfer catheters (etc), allwin etc stylets and soft obturators Allwin Medical Devices, Inc. k200248 07/01/2020

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