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510(k) K130049

MONOJECT 12ML SYRINGE by Nipro Medical Corporation — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2013
Date Received
January 8, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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  • K140191 — ELISIO-H HEMODIALYZER (April 14, 2014)

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