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510(k) K152410

Top Fine Pen Needle by Medexel Co.,Ltd — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2016
Date Received
August 26, 2015
Clearance Type
Traditional
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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