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510(k) K150921

Orbit Infusion Set by Ypsomed AG — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2016
Date Received
April 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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