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510(k) K110105

BD PEN NEEDLE by Becton, Dickinson and Company (BD) — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2011
Date Received
January 13, 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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