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510(k) K150874

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) by Novo Nordisk, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2015
Date Received
April 1, 2015
Clearance Type
Special
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

Other clearances by Novo Nordisk, Inc.

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  • K173479 — NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (January 17, 2018)
  • K162602 — NovoPen Echo (October 18, 2016)
  • K133738 — NOVOFINE PLUS 32G 4 MM (May 21, 2014)
  • K123766 — NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN (August 15, 2013)
  • K093109 — NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') (June 18, 2010)
  • K090111 — FLEXPEN NEEDLE (February 1, 2010)

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