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FDA 510(k) Applications Submitted by YPSOMED AG
FDA 510(k) Number
Submission Date
Device Name
Applicant
K110312
02/02/2011
CLICKFINE AUTOPROTECT PEN NEEDLE
YPSOMED AG
K130468
02/25/2013
ORBIT INFUSION SET
YPSOMED AG
K131123
04/22/2013
CLICKFINE AUTOPROTECT PEN NEEDLE
YPSOMED AG
K131125
04/22/2013
CLICKFINE PEN NEEDLE
YPSOMED AG
K100436
02/16/2010
CLICKFINE PEN NEEDLE
YPSOMED AG
K102108
07/27/2010
CLICKFINE PEN NEEDLE
YPSOMED AG
K150921
04/06/2015
Orbit Infusion Set
YPSOMED AG
K171984
06/30/2017
Clickfine Pen Needle, Penfine Classic Pen Needle
Ypsomed AG
K152514
09/02/2015
Clickfine AutoProtect Pen Needle
YPSOMED AG
K163400
12/05/2016
Orbit Inserter
YPSOMED AG
K150662
03/13/2015
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
YPSOMED AG
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