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510(k) K140131

SUB-Q SUBCUTANEOUS TISSUE INFUSION SET by Emed Technologies Corporation — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2014
Date Received
January 17, 2014
Clearance Type
Special
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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