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510(k) K123766

NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN by Novo Nordisk, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2013
Date Received
December 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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