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510(k) K102108

CLICKFINE PEN NEEDLE by Ypsomed AG — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2010
Date Received
July 27, 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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  • K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE (January 26, 2012)

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