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510(k) K111797

27 G X 1/2 K-PACK SURSHIELD NEEDLE by Terumo Europe N.V. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2011
Date Received
June 24, 2011
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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  • K150263 — K-Pack II Needle-21G x 2 (April 1, 2015)
  • K133894 — SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (March 18, 2014)

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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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