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510(k) K120191

PUSH-ON NEEDLE 30GX8MM by Scandinavian Health Limited — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2012
Date Received
January 23, 2012
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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