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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 13 Results
ProductCode: FPA Applicant: UNOMEDICAL A/S Decision Date To: 01/28/2022
 
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medtronic extended infusion set Unomedical A/S K210544 07/16/2021
neria guard infusion set Unomedical a/s K192647 12/13/2019
minimed mio advance infusion set Unomedical A/S K173879 03/05/2018
unomedical comfort subcutaneous infusion set, unomedical comfort short subcutaneous infusion set, unomedical neria soft subcutaneous infusion set, medtronic silhouette subcutaneous infusion set, medtronic silhouette paradigm subcutaneous infusion set, roche accu-chek tender subcutaneous infusion se UNOMEDICAL A/S K162812 11/01/2017
minimed quick-set® minimed sure-t® minimed silhouette® minimed mio® UNOMEDICAL A/S K160648 08/10/2016
neria soft 90 infusion set UNOMEDICAL A/S K132142 10/08/2013
asante conset and asante comfort subcutaneous infusion sets for use with asante pearl infusion pumps UNOMEDICAL A/S INFUSION DEVICES K120872 04/20/2012
paradigm quick-set ii and quick-set ii subcutaneous infusion sets UNOMEDICAL A/S K070430 04/04/2007
intuition infusion sets UNOMEDICAL A/S K061374 07/31/2006
comfort and inset subcutaneous infusion sets for use with abbott infusion pumps UNOMEDICAL A/S K051264 09/01/2005
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