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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 185 Results
ProductCode: FPA Applicant: Y Decision Date To: 01/22/2017
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glucopro infusion set, model gpisxxxxxxxx series NIPRO DIABETES SYSTEMS, INC. K011120 05/08/2001
halo ambulatory infusion system ZYNO MEDICAL LLC. K140783 10/17/2014
halo ii ambulatory infusion system (also with trade names nimbus ii ambulatory infusion system, evaa ambulatory infusion system) ZYNO MEDICAL LLC K153193 08/30/2016
high-flo super26 subcutaneous needle sets Repro-Med Systems, Inc. dba RMS Medical Products K180843 04/04/2019
i.v. administration set MEDISYSTEMS CORP. K811837 07/10/1981
i.v. transfer spike LYPHOMED, INC. K842678 10/09/1984
imed technology intravascular administration set, imed technology extension set IMED TECHNOLOGY, INC. K150513 05/28/2015
in vision-plus nano with neutral advantage technology RYMED TECHNOLOGIES, INC. K093489 07/29/2010
infusion set-52-05-1 20 drops-mi vol Y K833033 11/07/1983
infusion sets #'s 124 & 142 personal PACESETTER SYSTEMS K831445 09/12/1983
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