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510(k) K093109

NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') by Novo Nordisk, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2010
Date Received
October 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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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)
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  • K133738 — NOVOFINE PLUS 32G 4 MM (May 21, 2014)
  • K123766 — NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN (August 15, 2013)
  • K090111 — FLEXPEN NEEDLE (February 1, 2010)

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