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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
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paracontrol abnormal immunoglobulin cont Diagnostica, Inc. k800398 03/12/1980
space 360 delivery system Dfine, Inc. k070351 06/29/2007
conometric abutments Dentsply Sirona, Inc. k183079 07/10/2019
capture impression material Dentsply Intl. k943574 08/23/1994
ster-mate sterile lavage kit Dentsply Interntional k082973 01/29/2009
infusion pump Delta Medical Industries k832470 02/28/1984
deka jr. Deka Research & Development Corp. k863204 09/03/1986
luxalloy caps (predosed capsules) Degussa AG k902248 07/13/1990
rmu-2000 automated chest compression system Defibtech, LLC k211289 11/09/2021
data-zyme glucose hexokinase colozimetri Data Medical Associates, Inc. k801051 05/23/1980

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