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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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il test(tm) triglyceride Instrumentation Laboratory CO k931116 03/28/1994
s500 seating system Fortress Scientific , Ltd. k933863 03/28/1994
synelisa ana total Elias U.S.A., Inc. k935468 03/25/1994
bimetric total hip system Biomet, Inc. k921224 02/16/1994
phoenix bone screws pbs-type series Phoenix Bioengineering, Inc. k930125 12/30/1993
cedia digoxin plus assay Microgenics Corp. k934168 12/29/1993
clearview positive and negative urine hcg contol set Unipath , Ltd. k934923 12/29/1993
duoderm hydrocolloid gel Convatec, A Division of E.R. Squibb & Sons k931618 12/10/1993
xenon light source illuminator Stephen Chakoff, Inc. k932631 11/16/1993
pituitary board Bionix Development Corp. k933614 10/07/1993

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