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510(k) K131641

MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) by Nipro Medical Corporation — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2013
Date Received
June 4, 2013
Clearance Type
Traditional
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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