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510(k) K110850

K-PACK II NEEDLE- 27G & 30G THIN WALL by Terumo Europe N.V. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2011
Date Received
March 28, 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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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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