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510(k) K130690

Z-800 INFUSION SYSTEM by Zyno Medical, LLC — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2013
Date Received
March 14, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K120685 — ZYNO MEDICAL ADMINISTRATION SET (September 7, 2012)
  • K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (July 8, 2010)
  • K071545 — Z-800 VOLUMETRIC INFUSION PUMP (October 31, 2007)

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