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510(k) K191359

Nipro Syringe by Nipro Medical Corporation — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2019
Date Received
May 21, 2019
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)
  • K140136 — NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (February 14, 2014)

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