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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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lexur enamel coating-porcelain repair-bonding veneers Dent Zar, Inc. k960600 04/26/1996
levine eosin methylene blue agar The Montana Deaconess Medical Center k841751 05/31/1984
legionella indirect fluor. antibody Centers For Disease Control and Prevention k812007 09/08/1981
latex patient examination gloves Encore Products, Inc. k892573 07/14/1989
latex examination gloves Quingdao Latex Factory k893235 09/12/1989
latex examination gloves Jiahn Chiaur Enterprise Co., Ltd. k894195 07/28/1989
latex examination gloves Top Glove Sdn. Bhd. k913409 09/27/1991
lasersonics surgical laser systems and accessories Heraeus Surgical, Inc. k943716 03/14/1995
kyphon vue bone cement Tecres S.P.A. k220131 04/18/2022
kova trol iii Icl Scientific k780482 05/03/1978

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