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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
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clostridium difficile agar base Oxoid U.S.A., Inc. k802495 12/18/1980
cmv test Gull Laboratories, Inc. k853137 11/14/1985
coagulation factor viii deficient substrate plasma American Dade k853462 08/29/1985
cobalt, 29.5% chromium alloy dental bake-on alloy Austenal Dental, Inc. k862667 07/31/1986
cobas(r)-fp reagents for gentamicin and cobas(r)-fp gentamicin calibrators Roche Diagnostic Systems, Inc. k945523 03/09/1995
coil field extender Resonex, Inc. k911800 07/03/1991
combion skin test - four prong Nicholas H. Maganias k833999 09/05/1984
combo fetal scalp electrode/legplate Utah Medical Products, Inc. k905830 03/29/1991
commander iii non-invasive blood pressure system Cardiocom, LLC k053304 12/30/2005
compression anastomosis clip (cac) Niti Medical Technologies , Ltd. k041751 09/16/2004

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