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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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alta dressing frame Alta Medical Products, Inc. k926380 08/06/1993
phoenix bone screws pbs-type series Phoenix Bioengineering, Inc. k930125 12/30/1993
marco standard keratometers Marco Ophthalmic, Inc. k930444 08/09/1993
thyroglobulin autoantibody immunoassay kit Nichols Institute k930777 04/08/1993
il test(tm) triglyceride Instrumentation Laboratory CO k931116 03/28/1994
histofreezer Solarcare Technologies Corp,Inc. k931299 08/11/1993
duoderm hydrocolloid gel Convatec, A Division of E.R. Squibb & Sons k931618 12/10/1993
new england medical grounding pad New England Medical, Inc. k931982 10/05/1993
culture-pak collection and transport system Medical Packaging Corp. k932337 08/16/1994
xenon light source illuminator Stephen Chakoff, Inc. k932631 11/16/1993

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