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510(k) K100705

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2010
Date Received
March 12, 2010
Clearance Type
Abbreviated
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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  • K130690 — Z-800 INFUSION SYSTEM (June 12, 2013)
  • K120685 — ZYNO MEDICAL ADMINISTRATION SET (September 7, 2012)
  • K071545 — Z-800 VOLUMETRIC INFUSION PUMP (October 31, 2007)

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