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510(k) K160860

MiniMed Quick-serter by Medtronic Minimed — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2016
Date Received
March 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type

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Other clearances for product code KZH

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  • K124026 — LOBSTER AUTO-INJECTOR (September 13, 2013)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K082587 — AUTO-SAFETY INJECTOR-2 (ASI-2) (October 2, 2008)
  • K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI) (March 7, 2008)
  • K062339 — DERMOTHERAP GUN (February 5, 2007)