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510(k) K110312

CLICKFINE AUTOPROTECT PEN NEEDLE by Ypsomed AG — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2012
Date Received
February 2, 2011
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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  • K131123 — CLICKFINE AUTOPROTECT PEN NEEDLE (July 5, 2013)
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  • K130468 — ORBIT INFUSION SET (March 19, 2013)
  • K102108 — CLICKFINE PEN NEEDLE (November 23, 2010)

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