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510(k) K141749

CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT by Facet Technologies, LLC — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2014
Date Received
June 30, 2014
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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  • K140568 — CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT (May 13, 2014)
  • K133100 — CAREFINE PEN NEEDLE (January 23, 2014)

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