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510(k) K100436

CLICKFINE PEN NEEDLE by Ypsomed AG — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
February 16, 2010
Clearance Type
Special
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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  • K130468 — ORBIT INFUSION SET (March 19, 2013)
  • K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE (January 26, 2012)

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