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510(k) K152183

EXELINT SecureTouch Safety Hypodermic Needle by Exelint International, Co. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2015
Date Received
August 5, 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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